The lot affected was manufactured on production work order 14097259

Descriptor- lntraoperative Procedure Bag

REF 86-001737, Lot Number 25660996 REF 86-001781, Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 REF 86-001641, Lot Numbers: 25573171, 25765667, 25834853, 25834861 REF 86-001619, Lot Number 25573155 REF 86-001669, Lot Numbers: 25313484, 25702324, 25977977

Anesthesiology Devices

2

No

Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.

Custom anesthesia kits labeled as follows: || (1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Number 25660996 || (2) DeRoyal (R) Adult Anesthesia Circuit, REF 86-001781, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 || (3) DeRoyal (R) Latex Safe Anesthesia Kit, REF 86-001641, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25573171, 25765667, 25834853, 25834861 || (4) DeRoyal (R) Custom Anesthesia Kit, REF 86-001619, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Number 25573155 || (5) DeRoyal (R) Anesthesia Kit, REF 86-001669, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25313484, 25702324, 25977977 || Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Lot Numbers: 25402698, 25834829

Cardiovascular Devices

2

No

Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.

DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: || Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Lot Number 15125173

Cardiovascular Devices

2

No

Nationwide Distribution to MD, NY, and IL

DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

REF 50-12127: Lot numbers: 36207249, 36396502, 36912175, 38441725;   REF 53-1931: Lot numbers: 33718713, 34910141, 34939139, 35588220, 35814688, 35850671, 35850689, 35862524, 36047791, 36095291, 36517319, 36746146, 36753451, 36517319, 37137174, 36917953, 37581806, 37700140, 37854413, 37794561, 37994256, 38180166, 38222135, 38250970, 38266955, 38475255, 38518382, 36917953;  REF 53-1932: Lot numbers: 34374561, 34374570, 34374561, 34492891, 34740023, 34740031, 34910133, 34939067, 34910133, 34939067, 35031309, 35170747, 35503361, 35128080, 35503361, 35128080, 35531442, 35850654, 35850662, 35531442, 35850662, 35862532, 36095267, 36139733, 36426151, 36426169, 36464675, 36746154, 36753442, 36917945, 36746154, 36962762, 37137182, 37137238, 37246240, 37259219, 37287586, 37700123, 37287586, 37581785, 37700158, 37794553, 37869762, 37994230, 38222127, 37700158, 37794553, 37994248, 38222127, 38250945, 38266947, 38475263, 38518374, 37137182, 37259219;   53-1933: Lot numbers: 33718705, 34374545, 34492912, 34939059, 34910125, 34939059, 35086692, 35503337, 35850638, 35850646, 36095259, 36426142, 36746138, 36753434, 36917937, 36962771, 37137166, 37259180, 37287594, 37581769, 37581777, 37854405, 37854421, 37869771, 38467888, 38250937, 37259180;  REF 5-3479-1: Lot numbers: 1346014X, 2002010X;  REF 89-3605: Lot numbers: 35199494, 35332531, 33714317, 34508890, 34588789, 34701278, 34508890, 35609158, 35733546, 35199494, 35332531, 35609158, 36020265, 36318555, 37012777, 37197994, 37866668, 36740916, 37392423, 37478286, 37652467, 38007267, 38185784, 38497500, 38678503, 34508890;   REF 89-3606: Lot numbers: 38086153, 33671273, 33477059, 33804611, 34588797, 34883729, 34508902, 35609166, 35733562, 35095337, 35399517, 35244161, 36053948, 36395614, 36421448, 37198006, 36813661, 37150213, 36665135, 37012785, 37454874, 37652475, 37866676, 38007275, 38160798, 38134063, 38317871, 38275739, 38413062, 38729083;   REF 89-3607: Lot numbers: 38221298, 37221034, 33501485, 33478588, 33805577, 34447791, 34785555, 34931903, 34987561, 35610335, 34987561, 35245219, 36207337, 35848642, 36021508, 36479421, 36962244, 37198794, 37455421, 37325992, 37867791, 38086735, 38221298, 38269523, 38498140;   REF 89-3609: Lot numbers: 33671281, 34930863, 34588800, 35783990, 35332558, 36318571, 37012793, 37454882, 38086161, 38372184, 38729104;   REF 89-3610: Lot numbers: 37866705, 33618931, 33747565, 34508929, 34823689, 35244179, 35784001, 35518184, 35733589, 34959914, 35124804, 35332566, 36020290, 36137236, 36318580, 36053964, 36478428, 36911332, 36813687, 37454891, 38522306, 37267219, 37392440, 37866705, 38038514, 38086170, 38246920, 38275755, 38497526, 38831803, 38609989;  REF 89-3611: Lot numbers: 33477083, 33533698, 33692373, 33831257, 34508937, 34737422, 34737414, 35244187, 35733597, 35244195, 35487681, 35896071, 36192569, 36053972, 36478436, 37929711, 36911359, 36543808, 36740959, 37198014, 37454903, 37524060, 37588581, 37274291, 37815035, 38086188, 38185792, 38275763, 38497534, 38729121, 38522314, 38729112, 33477083, 35487681, 36478436, 37929711, 36543808, 37274291, 37815035, 38185792, 38497534;   REF 89-3808: Lot numbers: 37198815, 35734821, 33599208, 34510375, 34825140, 35734821, 35459022, 35280250, 35400451, 35734821, 35952141, 36055433, 36479439, 36579860, 36666171, 37013711, 37393080, 37525089, 37867804, 38008008, 38186138, 38221301, 38276344, 38498158, 38781949, 38729884, 35096372, 34510375;   REF 89-3809: Lot numbers: 33549278, 33748875, 34510383, 35784731, 35400469, 36666189, 36912511, 37653531, 37378963, 37867812, 38032243, 38345338, 38746246, 37867812;  REF 89-4137: Lot numbers: 33692402, 34737502;  REF 89-4798: Lot numbers: 37915888, 38086727, 38230397;  REF 89-4832: Lot numbers: 34447361, 34589941, 36479199, 37575529, 37839192, 38497948;   REF 89-4902: Lot numbers: 34631118, 34750791, 36244744, 37661398, 38401811, 38412991;   REF 89-4935: Lot numbers: 37197935, 33533612, 33618907, 33747469, 34431482, 34792675, 33888510, 34930783, 34588711, 35518109, 35659315, 35051537, 35199283, 36318491, 36137172, 36192518, 36020206, 37012742, 36911244, 36576896, 36740801, 37078531, 37454794, 37652408, 38576099, 37741961, 37814930, 37866609, 38007216, 38086102, 38142629, 38246874, 38632417, 38365380;   REF 89-5057: Lot numbers: 33669448, 34833123, 35846170, 36017998, 36316285, 37333061, 37813144;   REF 89-5059: Lot numbers: 33595653, 33474608, 33618042, 33744858, 35026497, 35242157, 35670944, 35606483, 35039589, 35330851, 35894489, 36316357, 35606483;  REF 89-5246: Lot numbers: 33549008, 35896530;  REF 89-5259: Lot numbers: 34738556, 34824737, 35518969, 35784458, 35951973, 36396473;   REF 89-5609: Lot numbers: 35072602, 35530394, 36132953, 38400051, 38737542;  REF 89-5611: Lot numbers: 35514255, 37075882, 37863264;   REF 89-5978: Lot number 37263824;  REF 89-5979: Lot numbers: 37263841, 34440291, 34682353, 35328436, 37388758;  REF 89-5985: Lot numbers: 35560892, 35740244, 34966057, 35946550, 35990921, 36568503, 37622701, 37725494, 37973033, 38219382, 38090697, 38455705, 38743934, 38689131;   REF 89-6263: Lot numbers: 38341935, 33616012, 34749079, 35479710, 36068710, 33384258, 33616012, 34749079, 35479710, 36189221, 36068710, 36569055, 37036437, 37194321, 37773496, 38341935, 38778782;   REF 89-6264: Lot numbers: 35122585, 36049851, 36132451, 36327187, 36735527, 35122585, 36327187, 36957306, 36661011, 37520376;   REF 89-6341: Lot numbers: 33740890, 35239126, 35603101, 37194494, 36735551, 37569639, 37811261;   REF 89-6354: Lot numbers: 34749159, 35239151, 37773648;  REF 89-6374: Lot numbers: 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811, 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811;   REF 89-6377: Lot numbers: 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941, 38518905, 38630180, 38090734, 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941;   REF 89-6378: Lot numbers: 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645, 38495176, 38575504, 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645;    REF 89-6396: Lot numbers: 33592111, 35513640, 37126993, 36868856, 36735535, 37194451, 38495141;  REF 89-6409: Lot number 36717054;  REF 89-6508: Lot numbers: 36818058, 37217975, 35887289, 33566422, 33688884, 33528400, 33828816, 34523838, 34351749, 34857651, 34868650, 35887289, 34730589, 34579516, 35549651, 35704972, 34966065, 35275725, 35414537, 36686981, 36131889, 35887289, 35959094, 36381837, 36444560, 36904773, 36568511, 36818058, 36877470, 36956952, 37145060, 37378040, 37441854, 37463551, 37519834, 37622719, 38654173, 37862131, 38219391, 38083729, 38243471, 38364897, 38676524, 38526921, 35082296;   REF 89-6798: Lot numbers: 35705131, 35428533, 35705131, 35240186, 35428533, 35859085, 37195251, 37774798;   REF 89-6799: Lot numbers: 33605971, 35740658, 35705140, 35481730, 36189861, 36263371, 36337617, 33605971, 34581851, 35740658, 35481730, 36189861, 36263371, 36462565, 37146791, 36906699;  REF 89-6855: Lot numbers: 33531553, 33669421, 34506237, 35516331, 35093163, 34928253, 35949662, 36476174, 37391017, 37776726, 38745104, 38496419;  REF 89-7017: Lot numbers: 35243125, 34671478, 36191751, 37196908, 37651026, 37865391, 38148043, 38780840;  REF 89-7018: Lot numbers: 35240805, 33530201, 33593906, 33801146, 33883727, 34733211, 35515258, 35091918, 35948627, 35781417, 35948627, 36392659, 36190230, 36571702, 37147111, 36958536, 37412877, 37323604, 37775432, 37949228, 38132341, 38244924, 38495900, 38630876;   REF 89-7020: Lot numbers: 33670511, 34735953, 35243150, 35732210, 35243150, 36052953, 36575295, 36910049, 36960214, 37333280, 37777593, 37950085, 38133386, 38269398, 38344028, 38631887;   REF 89-7022: Lot numbers: 37011416, 33802886, 35242392, 35657467, 37011416, 36191312, 37333124, 38133036, 38872699, 38631588;   REF 89-7025: Lot numbers: 33532548, 38031339, 33803521, 34671494, 35658216, 35732201, 35517157, 35517165, 35243141, 35339881, 34959164, 36575287, 36664079, 36052945, 36317237, 36960193, 37196916, 37454225, 37651034, 37391623, 37651042, 37865403, 37974141, 38166807, 38229898, 38344010, 38496751, 38745391;   REF 89-7026: Lot numbers: 35881135, 34442368, 34504469, 35781425, 34957329, 35240821, 35515266, 35781425, 33667872, 35396279, 35781425, 35604971, 36051133, 36190248, 36315039, 36474849, 36571729, 36571745, 36811112, 36737231, 37010464, 37432966, 37464651, 37648716, 37863969, 37973885, 38178402, 38229450, 38030811, 38342743, 38456046, 38630884, 38779638, 38495918;   REF 89-7028: Lot numbers: 33597202, 33887613, 34587364, 34392621, 34882101, 34587364, 35094431, 35517350, 35782920, 36575498, 36910250, 37197054, 38521493, 37651350, 37777753, 37992015, 38160595, 38463799, 38246031;   REF 89-7031: Lot numbers: 33530243, 34442448, 34733270, 34819065, 34957353, 35038990, 35240881, 35240899, 35515311, 35730071, 35530440, 35240899, 34957353, 35948694, 36051192, 36133981, 36051192, 36133981, 36392683, 36445431, 36571948, 36571921, 36603401, 36811155, 37010499, 37464677, 37571421, 37195657, 37323655, 37812416, 37775521, 37863985, 37991426, 38193944, 38132375, 38244983, 38342778, 38456089, 38495926, 38630921;   REF 89-7058: Lot numbers: 34505971, 34928077, 37021569;  REF 89-7061: Lot numbers: 37264878, 33667469, 34925888, 34441605, 35091432, 35514845, 35948248, 36314423, 36570662, 36050771, 37648231, 38630673, 37264878, 37863723, 38274120, 33667469, 33593332;   REF 89-7062: Lot numbers: 33746239, 34507660, 34630991, 35782807, 35398434, 35782807, 36394443, 37391615, 38573082, 37741515, 37791344, 37848494, 38496742, 33746239;   REF 89-7067: Lot numbers: 33669114, 34820331, 35397247, 36051889, 36662911, 37453628, 37864671, 38343252, 33669114;   REF 89-7068: Lot numbers: 34709085, 34506173, 33885693, 35026340, 34506173, 35026340, 35242000, 35782321, 35484332, 35516314, 35093112, 35168284, 35278221, 35397482, 34958217, 35960520, 35894374, 36316218, 36931501, 36573767, 36908766, 37453741, 37477460, 38677771, 37390946, 37649971, 37813128, 37905129, 37991805, 38195317, 38245572, 38132893, 38343341, 38727993, 38520600, 33885693   REF 89-7075: Lot numbers: 33486924, 34735700, 35027334, 35331352, 36191574, 36394283, 36676248, 36959977   REF 89-7076: Lot numbers: 33544848, 33615677, 33781325, 33870619, 34486942, 34351773, 34868772, 35791949, 35801895, 35513201, 35602538, 35751517, 35791949, 34966129, 35501809, 36650961, 36244285, 35928925, 36068437, 36327013, 37057051, 36904837, 36568626, 36603217, 36619551, 36734971, 37476336, 37810832, 37312374, 37948680, 38147833, 38083770, 38243526, 38341687   REF 89-7105: Lot numbers: 37245811, 33530032, 33742502, 34732904, 34874005, 34560428, 35781193, 35515055, 35240565, 35329818, 33883330, 36675456, 36016493, 36050940, 36314829, 36737071, 36811016, 37010384, 36687158, 37400497, 37464520, 37648468, 37648476, 38519676, 37389911, 37824020, 37874537, 37775141, 37991389, 38090873, 38263412, 38365064, 38689499, 34560428   REF 89-7114: Lot numbers: 33486705, 33691266, 33547782, 33802894, 34697328, 34391652, 34391644, 34939577, 34697328, 34670715, 35657475, 35606897, 35731532, 35026825, 35026833, 35093497, 35484914, 35397853, 35484914, 35846321, 35894631, 36052363, 36135530, 36316672, 36328121, 37148412, 36909312, 36476537, 36574305, 36812297, 36663463, 37011424, 37148421, 37453919, 37465346, 35606897, 37650331, 37777041, 37813275, 37949800, 38185371, 38031224, 38133044, 38220316, 38274883, 38245759, 38745227, 38830747, 38520968, 38520976, 38697801;   REF 89-7115: Lot numbers: 33546641, 35396092, 34733026, 35396092, 35781257, 36675472, 36288632, 37076404, 36571260, 36958464, 36811075, 37147065, 37195526, 37323461, 37824038, 37775213, 37949156, 38219956, 38132279, 38342655, 38446770, 38744646, 38495854, 38630788;   REF 89-7116: Lot Numbers: 34507723, 34671523, 33887322, 34959199, 35094262, 34671523, 34959199, 35782823, 35517190, 35530503, 34959199, 35243176, 35339901, 35517190, 36328340, 36052988, 36191785, 36317288, 36019150, 36394478, 36575332, 36664116, 36960222, 37454233, 37651085, 37413044, 37777614, 37813574, 37324800, 37950093, 38031355, 38178568, 38344044, 38412545, 38496769, 38245960, 38745403, 38831133, 38631908, 33887322, 36191785, 34507723, 35782823;   REF 89-7118: Lot numbers: 34818791, 35655429, 35705166, 35396084, 35329869, 36050991, 36571243, 36958456, 38630770, 37648548, 37928911, 38132261, 38711086;   REF 89-7189: Lot numbers: 37266363, 35658232, 33803547, 34445235, 33887314, 34536479, 35517173, 35732236, 34929707, 35094254, 35243168, 34929707, 36052961, 36575316, 36664108, 35782815, 36052961, 36317253, 36910057, 37021753, 37465573, 37266363, 37391631, 37777606, 37865411, 38196230, 38031347, 38344036, 38631895, 38521389, 33548136, 33803547;    REF 89-7191: Lot numbers: 35657441, 33886291, 34506721, 35657441, 35731508, 35026796, 35331037, 35416381, 36631576, 36052339, 36316664, 36574276, 36631576, 36909267, 37453901, 37650306, 38520950, 37324439, 37777032, 37949789, 38085441, 38274867, 38745201, 33474982, 33547758, 33802860, 33886291;   REF 89-7281: Lot numbers: 33881297, 33360521, 33881297, 33903100, 34376137, 34451985, 34923962, 35513210, 35414596, 36131918, 36444607, 36630274, 36818111, 37217983, 38273291, 38494915;   REF 89-7301: Lot numbers: 34507766, 35860211, 35243213, 36053024, 37148914, 37865438, 38042901, 38275077;   REF 89-7343: Lot numbers: 33597093, 33618675, 33803694, 33860672, 34685394, 34822475, 34671662, 35658398, 35658401, 35027756, 35094385, 35485933, 35398522, 35846743, 35846751, 35846760, 35860262, 35950604, 35992724, 37011803, 36317421, 36317430, 36664167, 37651288, 37699071, 37777729, 37915693, 38042927, 38133431, 38344095, 38496785, 38521469, 38745471, 37699071;   REF 89-7390: Lot numbers: 33886186, 35606707, 34958479, 36052283, 37219321, 37465291, 38412262;   REF 89-7391: Lot numbers: 34670571, 35093340, 38830641, 35894542, 37864996, 38038397, 38343480, 38830641;   REF 89-7398: Lot numbers: 33399257, 33746191, 34586951, 34822205, 34959148, 34507635, 35732172, 35331547, 36019088, 36664044, 35895158, 36317202, 36575252, 36881541, 37011731, 37443825, 37266339, 37333255, 37651000, 37813566, 37777551, 38412529, 38756794, 38521371, 38654747;   REF 89-7401: Lot numbers: 34958946, 33817682, 34958946, 35398223, 36317042, 36739325, 38573074, 37865315, 38133327;   REF 89-7550: Lot numbers: 33486596, 33802579, 34958292, 36052152, 37021622, 37453791, 37650058, 38148001, 38520722;   REF 89-7602: Lot numbers: 35399146, 34741481, 34445868, 34736964, 33888106, 35517931, 34959666, 35399146, 35847421, 36317982, 36740318, 37391990, 37778289, 38185557, 38807432, 38497075, 33888106;   REF 89-7620: Lot numbers: 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565, 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565;   REF 89-7736: Lot numbers: 34737916, 35544067, 36318846;  REF 89-7737: Lot numbers: 35488165, 35609561, 37198284, 37867071;  REF 89-7918: Lot numbers: 34931962, 36912600, 36742399, 38086786, 37867901, 38008059, 33619459, 36087056, 33478676, 34354350, 34885759, 34631281, 35610423, 36244841, 36087056, 36124961, 36319531, 37151460, 36912600, 36742399, 36666269, 37653591, 38576443, 37700019, 37867901, 38008059, 38086786, 38142768, 38345354, 38447385, 38498191, 38746254, 38781965, 33478676, 33619459, 34354350, 34561009, 34631281;   REF 89-7924: Lot numbers: 37267948, 34673772, 35784829, 35553596, 35400549, 35245340, 36912731, 36545184, 36555340, 36580406, 36742452, 36814680, 37079373, 37151507, 37267930, 38465065, 38807820, 38498211, 38553399, 38633022, 38690078;   REF 89-7990: Lot numbers: 34817916, 34503271, 34817916, 34503271, 36810460, 37010026, 37432843,  37905031, 38030598, 37323111;   REF 89-7991: Lot numbers: 33471301, 33800557, 34817924, 35481326, 35266423, 35947974, 37010034, 36391971, 36810478, 37323129, 37838683, 37774579, 38132009, 38677236;   REF 89-8004: Lot numbers: 33546085, 34487531, 34749440, 34388947, 34872253, 35740623, 35740631, 35654776, 35072629, 35184292, 35240004, 35395356, 35947966, 35991764, 36661636, 36133139, 36314044, 36418564, 36906373, 37076033, 37195075, 37452810, 37570269, 37264704, 37273432, 37400251, 37838675, 37973691, 38084588, 38131997, 38244553, 38273987, 38441055, 38495643, 38519318, 38727281, 38779259;   REF 89-8010: Lot numbers: 34429761, 34366351, 36958051, 37146572, 37570285, 38244570, 38519326;   REF 89-8191: Lot numbers: 35867894, 35948723, 35887393, 36392712, 38371739;  REF 89-8198: Lot number 33546843;   REF 89-8249: Lot numbers: 35396578, 38342815, 35396578, 35388404, 38342815, 38446809, 38744742;   REF 89-8261: Lot numbers: 34785352, 35605237;   REF 89-8273: Lot numbers: 34733464, 34442544, 34733464, 36650443, 36907552, 37864136, 33667995, 34733464, 34390107;   REF 89-8308: Lot numbers: 35188293, 36315354, 34875551, 35188293, 36315354, 36675683, 38274429;  REF 89-8309: Lot numbers: 36811251, 37218855, 33801541, 34875518, 36811251, 37127427, 37218855, 37265395;  REF 89-8310: Lot numbers: 35893718, 36572545, 33500968, 34875315, 35837345, 36134246, 35893718, 36572545, 37521820, 37265379, 38006281;   REF 89-8311: Lot numbers: 33501098, 37928996, 38229548, 37195761, 37176780, 33501098, 37928996, 37195761, 38229548, 38496072;   REF 89-8372: Lot numbers: 33870900, 33870918, 34583419, 35039108, 36552368, 36717484, 37453281, 38496081, 33870900;  REF 89-8379: Lot numbers: 37195809, 37195809, 38245185;  REF 89-8394: Lot numbers: 34587874, 34736649, 36317675, 36420867;   REF 89-8407: Lot numbers: 34736462, 34952499, 35847017, 36192075, 36910381, 38185442, 38496873, 34587671;   REF 89-8409: Lot numbers: 34587698, 34792561, 34952528, 35950719, 35847033;  REF 89-8416: Lot numbers: 37777981, 37848700, 37791483, 38275173;  REF 89-8444: Lot numbers: 35398725, 35658566, 36053227, 36910348, 36881815, 37149175, 36724545, 37401051, 37454401, 38654771, 37777892, 38091139, 38105393, 37865569, 38091139, 38229986, 38263711, 38344239, 38745534, 38521573, 38553250, 37929243, 38553250;  REF 89-8445: Lot numbers: 35398741, 35658582, 37077757, 36317616, 36349001, 36881823, 36575746, 36664301, 37465653, 37651552, 37266507, 37391771, 37661128, 37937534, 38006643, 38133538, 38344255, 37937534, 37465653;   REF 89-8464: Lot numbers: 37929286, 37929286, 38160616, 37791491, 38073416, 38288433;  REF 89-8465: Lot numbers: 35751832, 35950794, 36019512, 36071100, 35895650, 36337852, 36739974, 37245976, 37454444, 38344301;  REF 89-8489: Lot number 38246268;  REF 89-8499: Lot numbers: 38246188, 36153447, 36420816, 36812959, 37077802, 36739860, 37324981, 37266531, 38085679, 38142493, 38185451, 38246188;   REF 89-8505: Lot numbers: 36291882, 36421333, 38085901;  REF 89-8547: Lot numbers: 36960986, 36987610;  REF 89-8548: Lot numbers: 36960978, 36987599;  REF 89-8549: Lot Numbers: 36987687, 36961129;  REF 89-8550: Lot number 36987581;  REF 89-8568: Lot numbers: 38497358, 37150088, 37197871, 38497358;  REF 89-8652: Lot numbers: 38007195, 38086090;  REF 89-8660: Lot number 38371982;  REF 89-8664: Lot number 38148094;  REF 89-8666: Lot numbers: 38166604, 38245062, 38256597;  REF 89-8673: Lot number 38590131;  REF 94-0245: Lot numbers: 33530841, 34505269, 33397294, 34390414, 33801955, 34390414, 34505269, 34584075, 35605632, 35483583, 35189472, 35025726, 35605632, 35949179, 36289213, 36811438, 36419591, 36540156, 37010755, 37195972, 37477187, 37522259, 37572192, 37323971, 37824206, 37864460, 38006387, 38132631, 38317417, 38317425, 38343068, 38727791, 38496224;   REF 94-0266: Lot numbers: 33534931, 33805551, 35489408, 34960595, 34960595, 37466621, 37506072, 37839248, 38498131, 38729876;  REF 94-0277: Lot numbers: 35030349, 36193238, 37839256, 38573234;  REF 94-0280: Lot numbers: 36620720, 38807782

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and country of Guatemala.

Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: || ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4832; TOTAL KNEE TRAY PGYBK, REF 89-4902; ORTHO SPINE TRAY, REF 89-4935; MAJOR EXTREMITY PACK, REF 89-5057; STANDARD LAP CHOLE PACK, REF 89-5059; UROLOGY CYSTO PACK, REF 89-5246; LAPAROSCOPIC CHOLE PACK, REF 89-5259; FACELIFT & EYELID PACK, REF 89-5609; FACELIFT PACK, REF 89-5611; LAPAROSCOPY PACK, REF 89-5978; HYSTEREOSCOPY TRAY, REF 89-5979; CABG PACK PGYBK A & B, REF 89-5985; OPHTHALMOLOGY PACK PGYBK, REF 89-6263; VASCULAR DRAPE PACK, REF 89-6264; HEART PACK PGYBK, REF 89-6341; SHOULDER PACK, REF 89-6354; MINOR CUSTOM PACK, REF 89-6374; CATARACT PACK PGYBK, REF 89-6377; SURGI-START KIT, REF 89-6378; PACEMAKER PACK, REF 89-6396; GENERAL LAPAROSCOPIC PACK, REF 89-6409; OPEN HEART PROCEDURE PACK TOTAL, REF 89-6508; TOTAL HIP PACK A&B;, REF 89-6798; KNEE PACK A&B;, REF 89-6799; MAIN OH SUPPLY A&B; PACK, REF 89-6855; CRANIOTOMY PACK, REF 89-7017; PACEMAKER PACK, REF 89-7018; GYN MINOR PACK, REF 89-7020; ENT MAJOR PACK, REF 89-7022; GENERAL MAJOR PACK, REF 89-7025; GENERAL MINOR PACK, REF 89-7026; PV PACK, REF 89-7028; GENERAL LAPAROSCOPY PACK, REF 89-7031; CRANIOTOMY PACK, REF 89-7058; LAPAROSCOPY PACK-LF, REF 89-7061; HEAD & NECK PACK, REF 89-7062; VAGINAL HYSTERECTOMY PACK-LF, REF 89-7067; C-SECTION PACK-LF, REF 89-7068; GYN LAPAROSCOPY PACK, REF 89-7075; OPEN HEART PACK, REF 89-7076; C-SECTION PACK, REF 89-7105; TOTAL KNEE PACK, REF 89-7114; ARTHROSCOPY ALL PACK, REF 89-7115; GENERIC ORTHO PACK, REF 89-7116; MINOR EENT PACK, REF 89-7118; COMPANION PACK, REF 89-7189; ENDO VASCULAR PACK, REF 89-7191; OPEN HEART BASIC PACK, REF 89-7281; CUSTOM ER HAND PACK, REF 89-7301; C-SECTION PACK, REF 89-7343; MINOR PACK-LF, REF 89-7390; EXTREMITY PACK, REF 89-7391; ANGIOGRAPHY PACK, REF 89-7398; ANGIOGRAPHY DRAPE PACK PEDI, REF 89-7401; C-SECTION PACK, REF 89-7550; LAMINECTOMY PACK, REF 89-7602; LAPAROSCOPY GEN/UROLOGY PACK, REF 89-7620; LAP CHOLE / APPY TRAY, REF 89-7736; BREAST/TUMMY PACK, REF 89-7737; BASIC PACK, REF 89-7918; LAP CHOLE PACK, REF 89-7924; ROBOTIC SUPPLY URO PACK, REF 89-7990; ROBOTIC SUPPLY GYN PACK, REF 89-7991; SET UP PACK, REF 89-8004; TRAUMA PACK, REF 89-8010; PACEMAKER PACK, REF 89-8191; E HAND PACK, REF 89-8198; NEUROSURGERY PACK, REF 89-8249; SURGERY PACK, REF 89-8261; EYE PACK, REF 89-8273; KNEE PACK, REF 89-8308; SHOULDER PACK, REF 89-8309; HAND PACK, REF 89-8310; PERI/GYN PACK, REF 89-8311; NEURO PACK, REF 89-8372; PODIATRY PACK, REF 89-8379; C-SECTION PACK, REF 89-8394; GENERAL SURGERY PACK, REF 89-8407; GENERAL MALE PACK, REF 89-8409; HAND PACK, REF 89-8416; TOTAL HIP PACK PGYBK, REF 89-8444; TOTAL KNEE PACK PGYBK, REF 89-8445; SURGICAL PODIATRY PACK, REF 89-8464; CATH LAB PACEMAKER PACK, REF 89-8465; BREAST PACK, REF 89-8489; HEAD/NECK PACK, REF 89-8499; EXTREMITY PACK, REF 89-8505; KNEE ARTHROSCOPY PACK, REF 89-8547; SHOULDER ARTHROSCOPY PACK, REF 89-8548; UROLOGY PACK, REF 89-8549; ENT PACK, REF 89-8550; LAMINECTOMY PACK, REF 89-8568; ANT CERV FUSION PACK, REF 89-8652; ENDO BROW FACELIFT PACK, REF 89-8660; PODIATRY PACK, REF 89-8664; GENERAL SURGERY PACK REF 89-8666; Basic Set Up Pack, REF 89-8673; C-SECTION TRAY PGYBK, REF 94-0245; UNIVERSAL BREAST TRAY, REF 94-0266; DR. HAND TRAY, REF 94-0277; FEM-POP TRAY, REF 94-0280 || Usage: general surgical

1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515

General and Plastic Surgery Devices

2

No

US Nationwide Distribution

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only || Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.

Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903

General and Plastic Surgery Devices

2

No

US Distribution to: NY

Custom sterile surgical packs labeled as follows: || GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO || Use: Shoulder Arthroscopy

(a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122

General and Plastic Surgery Devices

2

No

Distributed to states of: CA and MO.

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: || (a) Shoulder Arthroscopy Pack 89-8686.01 || (b) Shoulder Arthroscopy Pack 89-8686.02 || (c) Knee Arthro Pack 89-8687.01 || (d) Knee Arthro Pack 89-8687.02 || Product Usage: general surgical

Lot Numbers: 27273826, 27324507, 27388691, 27453704, 27567701, 27760202, 27784829, 27883843, 27883851, 27915382, 27970710, 28013209, 28103933, 28117702, 28158889, 28158897, 28373571, 28506329, 28550670, 28678471, 28736415, 28793591, 28854235, 28908619, 28929145, 29015901, 29083680, 29169619, 29206205, 29271816, 29468459, 29522443, 29577604, 29631367, 29694350, 29754130, 29799557, 29850826, 29914025, 29914130, 29963231, 30021654, 30092364, 30092612, 30134245, 30143441, 30253965, 30312507, 30385597, 30487930, 30538274, 30608228, 30608236, 30618098, 30728570, 30776441,  30819771, 30906532, 30957381, 30990041, 31074854, 31155540, 31202772, 31338426, 31469590, 31469717, 31576230, 31671966, 31726138, 31776514, 31776549, 31780847, 31835027, 31886529, 31938886, 31939011, 31990297, 32050811, 32128560, 32133377, 32247761, 32247796, 32302978, 32315875, 32355800, 32421037, 32484206, 32544336, 32550891, 32605910, 32689586, 32764742, 32817154, 32869069, 32933761, 33011857, 33087405, 33217089, 33293188, 33357866, 33425822, 33482579, 33482595, 33539361, 33609787, 33682221, 33736436, 33807644, 33807759, 33876287, 34373462, 34450051,  34518799, 34574037, 34624356, 4699631, 34762927, 34826581, 34856368, 34913078, 34963833, 35033777, 35097560, 35170675, 35230658, 35270297, 35327370, 35400670, 35470555, 35523231, 35544500, 35598559, 35636885, 35638881, 35737011, 35774701, 35798614, 35850620, 35862954, 35877929, 36081869, 36107299, 36142123, 36200119, 36273810, 36282581, 36283559, 36341325, 36399631, 36465555, 36465627, 36548211, 36746488, 36823826, 36888726, 37017295, 37079744, 37155364, 37215937, 37269038, 37269142, 37297899, 37462031, 37513707, 37808046, 37869551, 37931204, 37976189,  38032593, 38088239, 38144000, 38180553, 38235294, 38236166, 38270188, 38270807, 38329400, 38392994, 38393399, 38457217, 38457250, 38573891, 38676461, 38688584, 38688648, 38734991, 38823441, 38898602, 39013335, 39063738, 39076660, 39201803, 39260598, 39303623, 39303631, 39353436, 39413822, 39502403, 39515394, 39559549, 39661519, 39706238, 39762395, 39812313, 39877694, 40272115, 40453207, 40522604, 40754595, 40754608, 40887005, 40888462, 41039809, 41080140, 41080166, 41161581, 41213150, 41279829, 41322330, 41356978, 41411210, 41467459, 41470068, 41544872,  41544901, 41601099, 41669982, 41713883, 41762247, 41830537, 41891081, 41980754, 42026874, 42078789, 42175386, 42240731, 42324142, 42345980, 42346077, 42367054, 42367062, 42368698, 42383628, 42467477, 42561121, 42561156, 42642790, 42679146, 43045591, 43091889, 43127731, 43166001, 43217189, 43454011, 43487584, 43501391, 43542580, 43588166, 43641406, 43742899, 43789030, 43824510, 43875309, 43916895, 43953506, 44039767

General and Plastic Surgery Devices

2

No

MS & LA

SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694   GEO-MED TOTAL HIP PACK, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740

General and Plastic Surgery Devices

2

No

Nationwide Distribution including SD and NE.

Custom surgical kits and trays: || GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 || GEO-MED TOTAL HIP PACK, REF 89-6664.03 || surgical kits

REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

General and Plastic Surgery Devices

2

No

SC, FL, OH, NJ, OK, MN, AR

DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: || TOTAL JOINT PACK A&B;, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03

REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177;  REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071

General and Plastic Surgery Devices

2

No

SC, FL, OH, NJ, OK, MN, AR

DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: || TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; || KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; || TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; || PACEMAKER PACK, REF 89-8381.01;

REF 46-202N, Lot Numbers: 26835591 and 25191755; REF 46-204N, Lot Numbers: 28084357, 28075961, 27003412, 27749425, 27392690, 26036749, 25731731, and 25235543; REF 46-214N, Lot Numbers: 27507573, 27437325, 26970419, 26970275, 26641033, 26394853, 26094578, 26009222, 25621209, 25235800, 25241960, 25120957, 25068811

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- USA (nationwide)

Non-sterile wound closure strips, packaged as follows: || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-202N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-204N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-214N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849

REF 47-483, Lot Numbers: 27449271, 27199769, 26706212, 25465699, 25573374, 25750861, 25043496, 24808987; REF 47-491.12, Lot Numbers: 25402954, 25313425; REF 47-626.10, Lot Numbers: 27200029, 25573420, 25465752, 25750844, 25448039; REF 47-732.03, Lot Numbers: 27449300, 26140642, 26023315, 25573876, 24525899; REF 47-787.00, Lot Numbers: 27617924, 26733317, 25574596, 25362737, 25223251; REF 50-7104.05, Lot Numbers: 27559242, 27370028, 26754601, 26136539, 25490325; REF 50-7195.12, Lot Numbers: 27488798, 26742619, 26597992, 26414922, 26314711, 26270324, 26010477, 25893511, 25608717, 25369349, 25159165, 24832987, 24741575; REF 50-9786.03, Lot Numbers: 27489150, 27181278, 26676261, 26415634, 26599445, 26367361, 25609306, 25529701, 25358172, 25369533, 25024543; REF 50-12421.10, Lot Numbers: 26115201, 25697801, 25609031; REF 50-12892.09, Lot Numbers: 27473705, 27123297, 26971008, 26743099, 26384444, 26016941, 25609066, 25490165, 25357882, 25099537, 24853913; REF 50-12898.07, Lot Numbers: 27692561, 27489395, 27181850, 26863103, 26676981, 26280709, 26018760, 25558692, 25358560, 25100198, 24898599, 24747521; REF 50-12892.09, Lot Numbers: 27855439, 27425480, 27181391, 26801375, 26394440, 26385009, 26115703, 24795522, 24662674; REF 70-10770.05, Lot Numbers: 27473713, 26278810, 26017249, 25308108, 25044931; REF 70-1911.20, Lot Numbers: 27728448, 26801084, 26497676, 26384639, 26017257, 25609314, 25358181, 25099836; REF 89-0323.06, Lot Numbers: 24746229, 24684662; REF 89-1918.07, Lot Numbers: 27609721, 27244718, 27180603, 26870768, 26813624, 26676341, 26384663, 26166771, 26017345, 25415341, 25099895, 25024631; REF 89-2176.09, Lot Numbers: 26384698, 26115439, 26062891, 25839574, 25764496, 25609381, 25358261, 25099932, 24662041; REF 89-2703.08, Lot Numbers: 27287005, 26923532, 26115973, 25610008, 25397593, 24898775, 25086031, 25100649; REF 89-2995.10, Lot Numbers: 27473756, 26840649, 25396911, 25024851, 24746421; REF 89-3053.1111 and 89-3053.10, Lot Numbers: 27890710, 27854997, 27776474, 27824528, 27750821, 27588781, 27470310, 27223482, 26839921, 26783648, 26662088, 26398053, 26015420, 25876421, 25697406, 25594693, 25529103, 25396312, 25458894, 24897393, 25272820, 25141766, 24833234, 24661604; REF 89-3190.10, Lot Numbers: 27473473, 27226667, 26956561, 26784430, 26475688, 26279100, 25697879, 25340095, 25201984, 25024957, 24746481; REF 89-3338.11, Lot Numbers: 27078369, 26980588, 26957724, 26785221, 25597034, 25086103, 24898804, 24855134; REF 89-3351.07, Lot Numbers: 27197149, 26957732, 26729289, 26437972, 26394458, 26099037, 25878830; REF 89-3452.07, Lot Numbers: 25255245, 25308204; REF 89-3472.08, Lot Numbers: 27692406, 27227336, 26368612, 24775601; REF 89-3482.06, Lot Numbers: 25086200, 25027533, 24650868; REF 89-3559.11, Lot Numbers: 27487218, 27342668, 27758487, 27286053, 26728091, 26279290, 26609877, 26125371, 25877458, 25459740, 25647396, 25415392, 25308255, 25220843, 25142291, 24898126, 24746579; REF 89-3561.09, Lot Numbers: 27826064, 27648421, 27472711, 27408621, 27342684, 27286070, 27206332, 26956705, 27100335, 26784528, 26663241, 26578679, 26398504, 26279329, 26098190, 26017759, 25816743, 25647409, 25459758, 25340271, 25273507, 25142304, 25025132, 25025124, 24774705; REF 89-3565.12 and 89-3565.13, Lot Numbers: 27610108, 27474345, 27425594, 27286942, 26801527, 27182043, 26664374, 26207931, 26063739, 25597376, 25460679, 25309063, 25203197; REF 89-3564.06, Lot Numbers: 26958129, 26610114, 26553404, 26385367, 26437999, 25879277, 25648006, 25558916; REF 89-3831.10, Lot Numbers: 27649328, 27409033, 26956799, 26922821, 26728180, 26367652, 26098245, 25340360, 25084909; REF 89-3896.07, Lot Numbers: 25340394, 25220886, 24822498, 24806720; REF 89-4003.04, Lot Numbers: 27758541, 27472884, 27498363, 27226122, 27180283, 26956852, 26345031, 26017919, 25816786, 25764576, 25596015, 25025335, 24898214, 24854393, 24774828; REF 89-4049.01, Lot Numbers: 25839700; REF 89-4087.02, Lot Numbers: 25876439, 25458923, 24915301; REF 89-4150.05, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4185.08, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4195.08, Lot Numbers: 27360882, 26077532, 25339174, 25121159; REF 89-4270.06, Lot Numbers: 27689629, 26955665, 26726934, 26366633, 25876501, 26097154, 26277104, 25839339, 25594749, 25697465, 25083674, 24821575; REF 89-4712.09, Lot Numbers: 24599943, 25027710, 25027728, 25143227, 25342007, 25460601, 25597237, 25698521, 25745949, 25879058, 26020026, 26281699, 26398969, 26579073, 26664251, 26785361, 27181649, 27181657, 27197157, 27286838, 27370044, 27474193, 27759076, 27869195, 27903074, 27911752; REF 89-4932.03, Lot Numbers: 27225841, 26956001, 26727321, 25876914, 25339668, 25159499; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-4990.02, Lot Numbers: 27968433, 27636050, 27473182, 27226405, 26728817, 26957370, 26648850, 26368225, 25878258, 25596533, 25558545, 25341101, 25369584, 25085557; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-5032.01, Lot Numbers: 27758292, 27244523, 27542272, 27035271, 26820613, 26985952, 26781562, 26270383, 26384057, 26166033, 26010573, 26077209, 25893562, 25873748, 25763717, 25414859, 25159202, 24741639, 24772347; REF 89-5059.01, Lot Numbers: 27892037, 27867886, 27825029, 27757759, 27741693, 27699376, 27589476, 27527355, 27527371, 27499198, 27407636, 27341446, 27285085, 27224354, 27178378, 26783031, 26800823, 26921182, 26954718, 26783023, 26725827, 26725819; REF 89-5102.03, Lot Numbers: 27700357, 26648876, 26078050, 26037910, 25866450, 25732849; REF 89-5103.03, Lot Numbers: 27648801, 27590522, 27528446, 27499260, 27310498, 27226325, 27100626, 26841078, 26663726, 26345306, 25698214, 25308511, 25142697, 24823108; REF 89-5173.01, Lot Numbers: 26821069, 26280451, 26018559, 25839849, 25698265, 25558617; REF 89-5228.07, Lot Numbers: 26764404, 26704321; REF 89-5259.05, Lot Numbers: 25142814, 25221011, 24974150; REF 89-5293.07, Lot Numbers: 27970306, 27846524, 27206586, 27182431, 26923735, 26821122, 25916736, 25817682, 25397809, 25028181, 24899217; REF 89-5341.01, Lot Numbers: 27221786, 26813472, 25893925, 25141475; REF 89-5383.04, Lot Numbers: 27697901, 27635807, 27385887, 27283397, 27310324, 27034420, 26955083, 26870602, 26726230, 26783373, 26632014, 26565296, 26226956, 26136256, 26090770, 25082946, 24820943; REF 89-5488.02, Lot Numbers: 26096813; REF 89-5545.02, Lot Numbers: 27174828, 26980668, 25879541, 25597632, 24916216, 24824653; REF 89-5559.08, Lot Numbers: 27140126, 26366246, 26726424, 25876041, 25594247, 25415077, 25022249; REF 89-5562.03, Lot Numbers: 27635831, 26986912, 26870611, 26366254, 26096848, 25916402, 25022257, 24953113, 24773690; REF 89-5565.03, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5655.01, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5657.04, Lot Numbers: 27220556, 26923815, 26369236, 26099635, 35242576; REF 89-5687.01, Lot Numbers: 27697531, 26345939, 26090921, 25597721; REF 89-5711.02, Lot Numbers: 27220652, 26958532, 26730212, 26566061, 25879681, 25840479, 25559089; REF 89-5820.01, Lot Numbers: 27467962, 27155598, 26726985, 26366668, 26062541, 25816233, 25529242, 25339246, 25099406; REF 89-5901.02, Lot Numbers: 25339220, 25307754, 25083711, 24853614; REF 89-6211.01, Lot Numbers: 27499067, 24821815; REF 89-6234.03, Lot Numbers: 27902514, 27643268, 27369668, 27175193, 26783875, 26366879, 26277585, 25697596, 25307826, 25084010, 24923192, 24598861; REF 89-6344.02, Lot Numbers: 27339371, 27175450, 26785900, 26665035, 26566117, 26651397, 26021281, 25648461, 25531676, 25398211, 25359044, 25309397, 25203816, 25143972, 24916371, 24826430; REF 89-6397.04, Lot Numbers: 27423450, 26399435, 25880171, 25598272, 25343261, 25087819, 25029766; REF 89-6478.03, Lot Numbers: 27889866, 27608964, 27525771, 27468623, 27221655, 26842450, 26730870, 26476541, 26283811, 25880454, 25648612, 25343472, 25490632, 25030071, 24750455, 24663984; REF 89-6509.01, Lot Numbers: 27339581, 26275467, 25838985, 25696921, 25557112, 25338112; REF 89-6642.03, Lot Numbers: 27787528, 27698111, 26675381, 26726686, 26344311, 25083421, 25338948, 24853446; REF 89-6671.01. Lot Numbers: 27222607, 27688896, 26100325, 26369973, 25880569, 25575919; REF 89-6724.01, Lot Numbers: 26284363, 25880737, 25294375, 25699356, 25088299, 24827838, 24750711, 24776760; REF 89-6814.03, Lot Numbers: 27902688, 27222834, 26094842, 25974215, 25777916, 25649738, 25019197, 24964568; REF 89-6816.03, Lot Numbers: 27255450, 27197026, 27176794, 26800778, 26723645, 26660058, 26394167, 26364021, 26314753, 26314745; REF 89-6830.05, Lot Numbers: 27750805, 27526782, 27340751, 27244195, 27197034, 27177367, 26952958, 26813261, 26781669, 26583700, 26061101, 26061098; REF 89-6844.02, Lot Numbers: 26364064, 26094922, 25080684, 25019234, 24922579; REF 89-6981.03, Lot Numbers: 27177375, 26836842, 26396921, 26660251, 26011120, 25080924, 24597260; REF 89-7061.01, Lot Numbers: 27757054, 27340419, 27176989, 26820656, 26660470, 26364494, 26095095, 25814959, 25592794, 25336977, 25019761; REF 89-7063.01, Lot Numbers: 27931139, 27178360, 26886276, 26820752, 26763997, 26724568, 26643186, 26565018, 26474503, 26397181, 26343722, 25748795, 25457841, 25268100; REF 89-7072.02, Lot Numbers: 27757071, 27645204, 26724242, 26396998, 26011533, 25744170, 24571140; REF 89-7112.01, Lot Numbers: 28036671; REF 89-7158.01, Lot Numbers: 27757986, 27699641, 26764041, 26725405, 26598485, 26166279, 24597964; REF 89-7449.02, Lot Numbers: 27868117, 27845505, 27868109, 27527611, 27407943, 27285376, 27224821, 26921043, 26782813, 26661157, 26674821, 26644365, 26474888, 26365526, 26114823, 26096223, 26013475, 26013467, 25875137, 25696761, 25593535, 25506833, 25395811, 25337806, 25337793, 25255000, 25021191, 25140966, 24952541; REF 89-7462.03, Lot Numbers: 27224047, 26838856, 26725528, 26365518, 26096207, 25271915, 25140958, 25021174, 25021158, 24896454, 24852902, 24820441; REF 89-7549.02, Lot Numbers: 27757732, 27471030, 26783103, 26693116, 26437817, 26275205, 26147713, 26042330, 26014048, 25875330, 25593703; REF 89-7613.01, Lot Numbers: 27868512, 27776888, 27825889, 27700111, 27758372, 27670696, 27472403, 27342473, 27285940, 27179848, 26731362, 26652429, 26370296, 26284620, 26136803, 26064416, 26022380, 26022371, 25944622, 25840831, 25765341, 25699410, 25088475, 25030804, 24649883; REF 89-7646.02, Lot Numbers: 27776896, 27656501; REF 89-7688.01, Lot Numbers: 25438130, 26097648; REF 89-7693.02, Lot Numbers: 26956166, 26922151, 26784069, 26727451, 26662635, 26662651, 26647048, 26344741, 26278123, 25647151, 26016537, 26016545, 25595389; REF 89-7758.01, Lot Numbers: 27609035, 27636826; REF 89-7871.01, Lot Numbers: 27911947, 27951818, 27962912, 28069245, 28076681; REF 89-7762.01, Lot Number: 27468981; REF 89-7768.01, Lot Numbers: 27930662, 27823701, 27469079, 27176153, 27176145; REF 89-7880.01, Lot Number: 28016899; REF 89-7896.01, Lot Number: 27993891; REF 89-6317.02, Lot Numbers: 27823269, 27525510, 27339143, 27221153, 27175222, 26842177, 26730491, 26579591, 26664981, 26498871, 26369551, 26099969, 25866581, 25818028, 25648436, 25531633, 25398182, 25203761, 25087561, 25029512, 24826384, 24750050; REF 89-6371.03, Lot Numbers: 27468463, 26958938, 26730634, 26665123, 26566150, 26369682, 25880147, 25793289, 25598256, 25029723, 24855450, 24750228; REF 89-6432.01, Lot Numbers: 27468501, 27175521, 26730773, 26638897, 26438043, 25029926, 25598344; REF 89-6501.02, Lot Number: 27964281; REF 89-6609.04, Lot Numbers: 27222560, 26366457, 26315721, 26096952, 25876287, 25396232, 25201327; REF 89-6643.01, Lot Numbers: 26344346, 26437876, 26147991, 25876279, 25022652, 25594554; REF 89-6717.02, Lot Numbers: 24643625, 24643617; REF 89-7900.01, Lot Numbers: 27981460, 27981494, 28016813, 28039

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- USA (nationwide)

Sterile sterile surgical kits containing Episeal products, packaged as follows: || DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal MINOR INTERVENTIO

REF 46-202, Lot Number: 346935; REF 46-203, Lot Numbers: 345495, 362263; REF 46-204, Lot Numbers: 350142, 344274; REF 46-206, Lot Numbers: 342708, 2360103; REF 46-212, Lot Numbers: 352631, 345230; REF 46-213, Lot Number: 350152; REF 46-214, Lot Numbers: 344278, 345232; REF 46-215, Lot Number: 345242; REF 46-216, Lot Numbers: 585961, 350276

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- USA (nationwide)

Sterile wound closure strips, packaged as follows: || DeRoyal EPISEAL, Wound Closure Strips, REF 46-202, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-203, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-204, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-206, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-212, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-213, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-214, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-215, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EPISEAL, Wound Closure Strips, REF 46-216, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849

RES 47-763.02, Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527  RES 47-773, Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745  RES 50-12437.08, Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765  RES 89-6818.01, Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296  RES 89-5649.01, Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531   RES 32-1695, Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758  RES 32-351, Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430  RES 89-6752.01, Lot Numbers: 20835339, 21511803, 23485821  RES 89-7212.01, Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321

General and Plastic Surgery Devices

1

No

Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI.

DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 || DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745 || DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, RES 50-12437.08, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765 || DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, RES 89-6818.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296 || DeRoyal (R) Universal Insertion Tray, RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 || DeRoyal (R) St. Suture Removal Kit, RES 32-1695, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic || Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758 || DeRoyal (R) Stainless Suture Removal Set, RES 32-351, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic || Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430 || DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, RES 89-6752.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20835339, 21511803, 23485821 || DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, RES 89-7212.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321 || Custom Surgical kits.

REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676

General and Plastic Surgery Devices

1

No

(USA) including Indiana

Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits

Lot Numbers: 27453624, 28013145, 28103757, 28117631, 28158774, 28215628, 28230174, 28252349, 28299104, 28317940, 28326230, 28405309, 28455138, 28486735, 28506265, 28568132, 28609969, 28631875, 28736343, 28793541, 28854180, 28908555 28961727, 29015839, 29083612, 29169512, 29214272, 29271744, 29339294, 29412771, 29522363, 29722357, 29754033, 29799485, 29850754, 30021523, 30092305, 30092604, 30134253, 30179216, 30728465, 30819738, 30957330, 31010691, 31015441, 31103782, 31296166, 31402993, 31469522, 31469709, 31576221, 31601554, 31671907, 32333862, 32335500, 32355746,  32550841, 32618796, 32689527, 32728688, 32764718, 32817091, 32834780, 32869000, 32933711, 32980699, 33011814, 33064334, 33087341, 33087350, 33197866, 33682175, 33736364, 33737623, 33783267, 34405461, 34699585, 34762863, 34768309, 34913043, 34939286, 34963841, 35170632, 35270238, 35270529, 35327337, 35544446, 35554708, 35580025, 35598516, 35710820, 35798577, 35828254, 35828449, 35870920, 35898261, 35952677, 36024274, 36081851, 36142094, 36142174, 36200101, 36273801, 36283541, 36309333 36341317, 36530441, 36605837, 36679545, 36953532, 37017210, 37079672,  37079787, 37083356, 37155305, 37189791, 37268916, 37331858, 37395771, 37396029, 37513643, 37654374, 38032551, 38088191, 38180246, 38235278, 38392951, 38457153, 38525030, 38551001, 38623300, 38625866, 38747370, 38788673, 38832507, 38832603, 38997758, 39013351, 39054022, 39076627, 39148951, 39579507, 39661447, 39706174, 39762352, 39812284, 39868780, 40017667, 40080121, 40149328, 40152447, 40264393, 40321968, 40322021, 40342363, 40380888, 40453186, 40453338, 40541549, 40607430, 40890010, 41161601, 41257048, 41263018, 41356935, 41411287, 41467416, 41544848,  41561980, 41601056, 41665404, 41740013, 41755485, 41755506, 42077436, 42077461, 42200721, 42332644, 42332661, 42406164, 42523723, 42523782, 42550246, 43479550, 43493941, 43531688, 43710715

General and Plastic Surgery Devices

2

No

MS & LA

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

REF 89-5260.04, Lot Numbers: 17636582, 18080838, 18146577, 18178608, 18298693, 18952510, 19419055, 19480569, 19518336, 19592131, 19901141, 20128925, 20176492, 20678329, 20724372, 20822626, 21815858, 21923306, 22732536, 24157900, 24291754, 24630752, 24747336, 24823319, 25460353, 25721453, 25784489, 26018591, 26037952, 26149090, 26280549, 27163133, 27206527; REF 89-3928.10, Lot Numbers: 17826968, 17857924, 18177242, 18407790, 19021830, 19140417, 19676836, 20009408, 20127383, 20495653, 20676711, 20887981, 21023367, 21184339, 21531020, 21717131, 21839219, 22016935, 22057411, 22204397, 22379218, 22585169, 22731293, 23094151, 23420711, 23874561, 24230804, 24429928, 24519157, 24774801, 26098270, 26316468, 26663347, 26728235, 26956844, 27180961, 27343071, 27826304, 27911550, 27931729; REF 89-2960.20, Lot Numbers: 17903599, 17935806, 18183757, 19140610, 19325542, 19480673, 19881274, 20208693, 20679330, 20822829, 21056863, 21067909, 21318966, 21422472, 21649319, 21816375, 22123933, 22587164, 22782189, 23422927, 23696522, 23949622, 24007645, 24073423, 24232105, 24432131, 24468732, 24576258, 24823474, 26019527, 26281120, 26368444, 26785141, 26923452, 27227192, 27473916, 27931868

General and Plastic Surgery Devices

1

No

Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.

Sterile surgical kits containing the Umbilicup device: || DeRoyal (R) VAGINAL DELIVERY PACK, REF 89-5260.04, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || DeRoyal (R) VAGINAL DELIVERY TRAY, REF 89-3928.10, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || DeRoyal (R) C-SECTION TRAY, REF 89-2960.20, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood

REF 89-7284.02: Lot Number: 26166359  REF 89-7237.01: Lot Number: 26013627  REF 89-7229.01: Lot number: 26013635  REF 89-5256.06: Lot Number: 26185242  REF 89-5277.02: Lot Number: 25793211  REF 89-6773.02: Lot Numbers: 25744022, 26010670, 26194641  REF 89-6196.03: Lot Number: 26097373  REF 89-7255.01: Lot Number: 26011736  REF 89-5275.05: Lot Number: 26063270  REF 89-5653.03: Lot Number: 26227422  REF 89-5654.03: Lot Number: 26020510  REF 89-5379.02: Lot Number: 26042735, 26282421  REF 89-5259.05: Lot Number: 25817201  REF 89-4718.04: Lot Number: 25840313  REF 89-4150.06: Lot Number: 25933077  REF 89-5317.02: Lot Number: 26078463  REF 89-3693.13: Lot Number: 26078447  REF 89-3694.13: Lot Number: 261449399  REF 89-6284.05: Lot Number: 25698986  REF 89-6285.06: Lot Number: 26078578  REF 89-6014.07: Lot Numbers: 26096856, 26147916  REF 89-3330.05: Lot Number: 26078367  REF 89-3331.04: Lot Numbers: 25817383, 26019720  REF 89-6467.05: Lot Number: 25880438  REF 89-6776.04: Lot Number: 26010688  REF 89-5257.08: Lot Numbers: 26125434, 26149102  REF 89-3479.08: Lot Numbers: 25873676, 25905092  REF 89-2910.09: Lot Number: 25695611  REF 89-6720.01: Lot Number: 26022048  REF 89-6629.01: Lot Number: 25839187  REF 89-2650.15: Lot Numbers: 25893423, 26010207, 26077111  REF 89-2644.17 A & B: Lot Number: 25894012  REF 89-6994.02: Lot Number: 25853544  REF 89-6996.02: Lot Number: 25853608  REF 89-6991.02: Lot Number: 25696032  REF 89-6998.03: Lot Number: 25853587  REF 50-4157.29: Lot Number: 25732507  REF 50-13010.19: Lot Number: 26009978  REF 89-6883.02: Lot Number: 25695911  REF 89-5382.03: Lot Number: 26020464  REF 89-3389.11: Lot Number: 26010291  REF 89-7114.02: Lot Number: 26012780  REF 89-7660.01: Lot Number: 26022656  REF 89-7549.02: Lot Numbers: 26042330, 26147713  REF 89-7546.02: Lot Numbers: 26025242, 26025717  REF 89-7536.02: Lot Number: 26022161  REF 89-7500.02: Lot Number: 26096063  REF 89-7495.02: Lot Number: 26256371  REF 89-7486.02: Lot Number: 26100624  REF 89-7484.01: Lot Number: 25875196  REF 89-7466.01: Lot Number: 26013301  REF 89-7465.03: Lot Number: 26096039, 26166244  REF 89-7451.02: Lot Number: 26166252  REF 89-7396.01: Lot Number: 26061573  REF 89-7448.03: Lot Number: 26166236  REF 89-7446.02: Lot Number: 26096549  REF 89-7365.01: Lot Numbers: 25838838, 26095765  REF 89-7357.01: Lot Number: 25874821  REF 89-7353.01: Lot Number: 26013862  REF 89-7327.02 & .03: Lot Numbers: 26012878, 26061611  REF 89-7326.02: Lot Number: 26013791  REF 89-6466.03: Lot Number: 26064133  REF 89-7198.02: Lot Numbers: 26011461, 26114751  REF 89-7192.02: Lot Number: 26013061  REF 89-7179.03: Lot Number: 26012229  REF 89-7177.03: Lot Number: 26061362  REF 89-7163.01: Lot Numbers: 26013299, 26114794  REF 89-7102.02: Lot Numbers: 25941536, 26011453  REF 89-7103.02: Lot Number: 26062031  REF 89-7105.03: Lot Numbers: 25941704, 26061371  REF 89-7117.01: Lot Numbers: 25744508, 25957301, 26095722  REF 89-7070.02: Lot Number: 26042137  REF 89-7029.02: Lot Number: 26011331  REF 89-7020.02: Lot Number: 26012704  REF 89-7076.03: Lot Numbers: 26012755, 26095749  REF 89-7069.01: Lot Number: 25814941  REF 50-13042.12: Lot Number: 25839929  REF 50-13200.13: Lot Number: 25878602  REF 89-6868.02: Lot Number: 25838731  REF 89-7001.03: Lot Numbers: 25854070, 25765333  REF 89-7011.02: Lot Number: 25853341  REF 89-7146.01: Lot Number: 26096186  REF 89-7185.01: Lot Number: 26011832  REF 94-0093.11: Lot Number: 26185197  REF 94-0097.11: Lot Number: 26136601  REF 89-7665.02: Lot Numbers: 26016318, 26097592  REF 89-7661.01: Lot Number: 26077698  REF 89-5113.09: Lot Number: 26018452  REF 89-7116.01: Lot Number: 26012712  REF 89-3695.13: Lot Numbers: 26042701, 26099432  REF 89-5396.03 A & B: Lot Number: 25792577  REF 89-6697.03: Lot Numbers: 25696067, 26146690  REF 89-7113.03: Lot Number: 25874231  REF 89-4164.06: Lot Number: 26098608  REF 89-4612.06: Lot Number: 25647601  REF 89-5720.02: Lot Number: 25746298  REF 89-6428.01: Lot Numbers: 25699111, 26021547  REF 89-6352.03: Lot Number: 26100026  REF 89-6348.03: Lot Number: 26021336  REF 89-6798.01: Lot Number: 25838686  REF 89-6799.01: Lot Number: 26094906

General and Plastic Surgery Devices

1

No

Nationwide Distribution.

Sterile surgical kits: || DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; || DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; || DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; || DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; || DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; || DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02 Lot Numbers: 25744022, 26010670, 26194641; || DeRoyal DISKECTOMY TRAY, REF 89-6196.03 Lot Number: 26097373; || DeRoyal MAJOR DRAPE PACK, REF 89-7255.01 Lot Number: 26011736; || DeRoyal EXTREMITY PACK PGYBK, REF 89-5275.05 Lot Number: 26063270; || DeRoyal SCOPE SHOULDER TRAY, REF 89-5653.03 Lot Number: 26227422; || DeRoyal KNEE SCOPE PACK, REF 89-5654.03 Lot Number: 26020510; || DeRoyal BILATERAL DRAPE, REF 89-5379.02 Lot Number: 26042735, 26282421; || DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05 Lot Number: 25817201; || DeRoyal MAJOR HIP PACK, REF 89-4718.04 Lot Number: 25840313; || DeRoyal SPINE PACK, REF 89-4150.06 Lot Number: 25933077; || DeRoyal ARTHROSCOPY TRAY, REF 89-5317.02 Lot Number: 26078463; || DeRoyal LARGE VASCULAR TRAY, Lot Number: 26078447; || DeRoyal SMALL VASCULAR TRAY, REF 89-3694.13 Lot Number: 261449399; || DeRoyal ASC VASCULAR PACK PGYBK, REF 89-6284.05 Lot Number: 25698986; || DeRoyal ASC BREAST PACK, REF 89-6285.06, Lot Number: 26078578; || DeRoyal ASC FOOT/ANKLE PACK, REF 89-6014.07 Lot Numbers: 26096856, 26147916; || DeRoyal ACUTE BURN EXCISION TRAY, REF 89-3330.05 Lot Number: 26078367; || DeRoyal RECONSTRUCTION TRAY, REF 89-3331.04 Lot Numbers: 25817383, 26019720; || DeRoyal FOOT PACK, REF 89-6467.05 Lot Number: 25880438; || DeRoyal TRAUMA PACK, REF 89-6776.04 Lot Number: 26010688; || DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5257.08 Lot Numbers: 26125434, 26149102; || DeRoyal CHILDRENs ORTHOPEDIC TRAY, REF 89-3479.08 Lot Numbers: 25873676, 25905092 || DeRoyal KNEE SCOPE, REF 89-2910.09 Lot Number: 25695611; || DeRoyal SPINE PACK PGYBK, REF 89-6720.01 Lot Number: 26022048; || DeRoyal OPEN SHOULDER PROCEDURE PACK, REF 89-6629.01 Lot Number: 25839187; || DeRoyal ORTHO TOTAL BASIC TRAY, REF 89-2650.15 Lot Numbers: 25893423, 26010207, 26077111; || DeRoyal ORTHO TOTAL HIP/KNEE TRAY, REF 89-2644.17 A & B Lot Number: 25894012; || DeRoyal MINOR/PLASTIC PACK, REF 89-6994.02 Lot Number: 25853544; || DeRoyal OPEN HEART PACK, REF 89-6996.02 Lot Number: 25853608; || DeRoyal GEN SURG UNIV PACK, REF 89-6991.02 Lot Number: 25696032; || DeRoyal PERI VASCULAR PACK, REF 89-6998.03 Lot Number: 25853587; || DeRoyal VASCULAR PACK, REF 50-4157.29 Lot Number: 25732507; || DeRoyal OPEN HEART B, REF 50-13010.19 Lot Number: 26009978; || DeRoyal GENERAL ORTHO PACK, REF 89-6883.02 Lot Number: 25695911; || DeRoyal HIP COUNTABLES TRAY, REF 89-5382.03 Lot Number: 26020464; || DeRoyal BASIC ORTHO TRAY, REF 89-3389.11 Lot Number: 26010291; || DeRoyal TOTAL KNEE PACK, REF 89-7114.02 Lot Number: 26012780; || DeRoyal ACF TRAY, REF 89-7660.01 Lot Number: 26022656; || DeRoyal HAND PACK, REF 89-7549.02 Lot Numbers: 26042330, 26147713; || DeRoyal ORTHO PACK, REF 89-7546.02 Lot Numbers: 26025242, 26025717; || DeRoyal THORACOTOMY PACK, REF 89-7536.02 Lot Number: 26022161; || DeRoyal LAPAROSCOPIC GYN PACK, REF 89-7500.02 Lot Number: 26096063; || DeRoyal ELG/AAA PACK, REF 89-7495.02 Lot Number: 26256371; || DeRoyal PEDI OPEN HEART PACK, REF 89-7486.02 Lot Number: 26100624; || DeRoyal TOTAL KNEE PACK, REF 89-7484.01 Lot Number: 25875196; || DeRoyal TOTAL KNEE PACK, REF 89-7466.01 Lot Number: 26013301; || DeRoyal CUSTOM TOTAL HIP PACK, REF 89-7465.03 Lot Number: 26096039, 26166244; || DeRoyal PERIPHERAL VASCULAR PACK, REF 89-7451.02 Lot Number: 26166252; || DeRoyal NEURO PACK, REF 89-7396.01 Lot Number: 26061573; || DeRoyal LABOR & DELIVER PACK, REF 89-7448.03 Lot Number: 26166236; || DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-7446.02 Lot Number: 26096549; || DeRoyal GENERAL MINOR PACK, REF 89-7365.01 Lot Numbers: 25838838, 26095765; || DeRoyal CUSTOM GENERAL MAJOR PACK, REF 89-7357.01 Lot Nu

Lot Number 44210051

General and Plastic Surgery Devices

2

No

Honduras, Belgium, and The Netherlands

DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 || Product Usage: general surgical

Lot Number 40004006

General and Plastic Surgery Devices

2

No

Distributed in LA and TN.

DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,

Lot Number 40259236

General and Plastic Surgery Devices

2

No

Distributed in LA and TN.

Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, || Custom surgical kit.