Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843

Cardiovascular Devices

2

No

Distributed in MA.

Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. || To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.

2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 2814828, 2814829, 2824496, 2858434, 2865404, 3030658, 2944397, 2977852, 2967214, 3000586, 3000590, 3030658, 3044689, 3071903, 3135658, 3088675, 3107504, 3188688, 3385844, 3188690, 3387046, 3397768.

Orthopedic Devices

1

No

Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.

Offset Reamer Handle, T5766 || Product Usage: || The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel¿ tube and outer housing.

GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.

Cardiovascular Devices

2

No

US: NY, TX.

Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. || The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers || in a bulk non-sterile configuration.

Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.

Orthopedic Devices

1

No

US Distribution to the state of : TX

Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).

Lot Number 30491 34897 2495656 2500095 2530283 2543053 2561976 2564518 2565790 2661673 2742720 2742725 2742726 2750445 2750447 2789308 2794360 2799474 2799475 2816992 2828788 2832952 2842658 2853782 2927152 2970762 2970798 3016939 3018991 3018992 3018993 3029352 3058553 3087813 3138763 3148504 3166474 3172918 3187998 3188004 3252224 3270048 3275306 5780001 2233370001 2233670001 2242190001 2259200001 2259210001 2271650001 2299480001 2299490001 2315880001 2315890001 2315900001 2315910001 2315920001 2322180001 2362520001 2363250001 2371900001 2371910001 2371920001 2371950001 2378420001 2459710001 2471740001 2487360001 2490460001 2491700001 2491710001 2504910001 2504930001 2504950001 2516110001 2518340001 2518350001 2518370001 2528690001 2553410001 2553440001 2553450001 2559210001 2566230001 2595380001 2627950001 2665630001 2724230001 2725870001 2725880001 2745160001 2766420001 2781250001 2782010001 3006450001 3007860001 3029980001 3037400001 3037470001 3038530001 3038560001 3038700001 3038720001 3038730001 3038740001 3038750001 3038760001 3038790001 3038800001 3038810001 3038820001 3038830001 3038840001 3038850001 3038860001 3039320001 3039330001 3046100001 3046200001 3060700001 3061130001 3061390001 3061930001 3062700001 3065930001 3066030001 3066060001 3068430001 3083790001 3086350001 3091750001 3092720001 3092730001 3093900001 4006680001 4007350001 4007560001 6342540001 6411410001 6411450001 7004290001 7008770001 7010540001 7011200001 7011240001 7014640001 7019390001 7022800001 7022810001 7023900001 7023900002 7032220001 7032230001 7033140001 7033830001 7036020001 7043510001 7046530001 7047580001 7054290001 7055180001 7064180001 7064340001 7067270001 7067280001 7068200001 7068300001 7068310001 7070520001 7072060001 7072070001 7072370001 7072370001 7072380001 7072610001 7075380001 7084500001 7085220001 7085620001 7085660001 7094580001 7094640001 7095080001 7095400001 7095410001 7097350001 7099830001 7100040001 7102740001 7102860001 7103040001 7103110001 7103350001 7103370001 7103380001 7103390001 7103560001 7104750001 7105030001 7105130001 7105350001 7105680001 7105720001 7106840001 7107610001 7108540001 7110290001 7112630001 7112770001 7113670001 7115160001 7116610001 7116620001 7116970001 7116980001 7117140001 7117150001 7117350001 7117490001 7117750001 7117760001 7117800001 7118530001 7118960001 7119760001 7119790001 7119800001 7124570001 7124580001 7124840001 7124940001 7126400001 7127770001 7128600001 7132050001 7132570001 7136610001 7139090001 7143650001 7143700001 7143710001 7145140001 7147570001 7148710001 7151430001 7152660001 7152930001 7153580001 7153610001 7153840001 7153850001 7153860001 7153870001 7155930001 7157020001 7157820001 7158050001 7161200001 7162790001 7165980001 7168000001 7168010001 7168270001 7170610001 7172520001 7175480001 7176040001 7176290001 7176330001 7177340001 7177350001 7177360001 7177370001 7179510001 7180460001 7180910001 7187030001 7187110001 7187650001 7187880001 7187890001 7188410001 7188420001 7188510001 7188520001 7190750001 7204710001 7206200001 7206930001 7212370001 7212490001 7215880001 7221210001 7228670001 7233210001 7233470001 7233490001 7234170001 7234260001 7234750001 7235840001 7236740001 7237910001 7241550001 7243420001 7244460001 7244900001 7252070001 7252330001 7253080001 7253090001 7253200001 7255070001 7255430001 7259520001 7261980001 7263100001 7264550001 7265500001 7266960001 7268590001 7269650001 7269660001 7273870001 7276290001 7276350001 7277140001 7284380001 7284420001 7284540001 7285000001 7285150001 7285170001 7285260001 7285660001 7285780001 7285820001 7288860001 7290770001 7290780001 7290900001 7307910001 7307920001 7307930001 7307940001 7307950001 7307960001 7307970001 7307980001 7307990001 8181080001  1003292 149467 2225930001 2233670001-62 2259190001 255441 2740689 2822781 2824203 2827399 2827401 2840353 2846027 2846037 3037410001 & 3037420001 3037430001 & 3037440001 3037450001 & 3037460001 385228 446559 468474 493607 502998 520684 565663 573358 600359 682102 701817 701838 711367 7120480001 7124590001 7124600001 7124610001 7132510001 7144330001 7144340001 7144350001 7148720001 7149430001 7153590001 & 7153600001 7177130001 7188440001 7212390001 7234560001 7234570001 7242420001 7242430001 7245010001 7245020001 7245030001 7255380001 7255390001 7255400001 7255410001 7263030001 7263040001 7267070001 7267950001 7267960001 7267970001 7267980001 7267990001 743422 773568 799699 841060 847862 877907 892823 968916 991034 CIDO00 DIAP00 MCT705-05A178 MCT705-07D851 MCT705-07D851 MCT705-09B220 MCT705-10F633 MS1063 No Lot Code OF-002-29515-0001 OF-002-32530-0001 OF-002-41119-0001 OF-002-42944-0001 OF-002-44825-0001 OF-002-44826-0001 OF-002-45448-0001 OF-002-45665-0001 OF-002-46173-0001 OF-002-49050-0001 OF-002-50500-0001 OF-002-50501-0001 OF-002-53569-0001 OF-002-58260-0001 OF-002-61715-0001 OF-002-72372-0001 OF-002-72373-0001 OF-002-72420-0001 OF-002-75542-0001 OF-003-01045-0001

Orthopedic Devices

1

No

Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGDOM, AUSTRALIA, AUSTRIA, BELGIUM, SWITZERLAND, NORWAY, SWEDEN, and TAIWAN.

Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: || Tl0600 ~ MMP3100CHA04 || T10491 MIMP3100CHA04 || T12230 M2M1P3100CHA04 || T15752 ~MMP3100CHA04 || T15949 ~MMP3100CHA04 || T17238 MMP3100CHA04 || T9954 MMP3100CHA04 || T9955 MMP3100CHA04 || T8468 MMP3100CHA04 || T11506 MMP3100CHA13 || T10281 MMP3100CHA04 || T8044 ~MMP3100CHA04 || T17203 87-4 20-00980 || T8177 ~ MMP3100CHA04 || T16934 MMP3100CHA62 || Tll340 SHP9109.00010 || T8043 ~ MMP3100CHA04 || T17321 MMPP3100CHA04 || T15311 GG920010029 || T1 7650 255000110 || T8143 803-t 1-103 || Tl4384 EK-00200690 || T1666t XEB227242 || T9316 MIMP3100CHA04 || Tl3642 500325 || T10753 ~MMP3100CH04 || T9348 ~ MMP3100CHA04 || T13480 MMP3100CHA042 || T10243 ~MIMP3001CHA08 || Tll209 ~ MMP300CHA12 || Tl0861 MMP3100CHA04 || T16427 MMP3100CHA04 || T9894 :-. MMP3100CHA04 || T12861 MMP3100CHA\041 || T8088 2002CUPI || T1661 1 T16611 || Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.

1000207 1001049 1001048 1000698 1000582 1000582 1001334 1001334 1002457 1002456 1002974 1002640 1003175 1003174 1003223 1003223 1003224 1003225 1003548 1003766 1003908 1004435 1004485 1004349 1004903 1005099 1004347 1005530 1005772 1005900 1009013 1008458 1009195 1009195 1009197 1009014 1009198 1009196 1009698 1009199 1009699 1009200 1009700 1011763 1010602 1012455 1012490 1013172 1013173 1013415 1013416 1013921 1013922 1514611 1614605 1714700 1953758 1953809 1953810 2124866 2073128 2116179 2141896 1953758 2150164 2157328 2209891 2302780 2302777 2302781 2302788 2362691 2407040 2407047 2407040 2407040 2898285 2898285 2898289 2971943 2904251 2919512 2938191 2978582 1004138 1004139 1004413 1004578 1004577 1004580 1004579 1005899 1005817 1009701 2324706 2920624 3092836 3092836 1006939   FC-002 FC-002 1012458 6280900001  8027435 8027436 8027434

Orthopedic Devices

1

No

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

Torque Limiting Adapter: || Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. || PRECIMED, Torque Limiting Adaptor, Non Sterile.. || Customer Number/Model: || 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, || 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, || MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.

2743160001 6091900001 3035180001 NOT AVAILABLE 6245730001 6245740001 6245750001 6245760001 6245770001 6245780001 6245790001 6245800001 6245810001 6245820001 6245830001 6245840001 6245850001 6245860001 6245870001 6245880001 6245890001 6245900001 6245910001 6245920001 6245930001 6245940001 6245950001 6245960001 6245970001 6245980001 6245990001 6246000001 6246010001 6246020001 6246030001 6246040001 6246050001 6246060001 6246070001 6246080001 6246090001 6246100001 6246110001 6246120001 6246130001 6246140001 6246150001 6246160001 6246170001 6246180001 6246190001 6246200001 6246210001 6246220001 6292870001 6420330001 6420340001 6422470001 6422480001 6422490001 6422500001 6422510001 6422520001 6422530001 6422540001 6422550001 6422560001 6441490001 6441500001 6448220001 6448230001 6448240001 6448250001 6448260001 6448270001 6448280001 6448290001 6448300001 6448310001 2091662 2091663 2091664 2091665 2091666 2091667 2091668 2091669 2091670 2091671 2091672 2091673 2091674 2091675 2091676 2091678 2091679 2091680 2091681 2091683 2091684 2091685 2091686 2091687 2091688 2091689 2091690 2091691 2091692 2091693 2091694 2091695 2091696 2091697 2091698 2091699 2091700 2091701 2091702 2091703 2091704 2091705 2091706 2091707 2091708 2091709 2091710 2091711 2091712 2169560 87437L01 87437L02 87437L03 87437L04 87437L05 87437L06 87437L07 87437L08 87437L09 87437L10 87437L11 87437L12 87437L13 87437L14 87437L15 87437L16 87437L17 87437L18 87437L19 87437L20 87437L21 87437L22 87437L23 87437L24 87437L25 87437L26 87437L27 87437L28 87437L29 87437L30 87437L31 87437L32 87437L33 87437L34 87437L35 87437L36 87437L37 87437L38 87437L39 87437l40 2367006 2367007 2367005 2367004 2367003 2367030 2367009 2367031 2367027 2367024 2367022 2367021 2367020 2367019 2367017 2367016 2367015 2367013 2367012 2367010 2367001 2366998 2366994 2366990 2366982 2366979 2366976 2366974 2366971 2366938 2366936 2366935 2366933 2366927 2366926 2366925 2366923 2366920 2366903 2366888 2461535 2461536 2461537 2461538 2461539 2461540 2461541 2461542 2461543 2461544 2461545 2461546 2461547 2461548 2461549 2461550 2461551 2461552 2461553 2461554 2461555 2461556 2461557 2461558 2461559 2461560 2461561 2461562 2461563 2461564 2461566 2461567 2461568 2461569 2461570 2461571 2461572 2461573 2461574 2461575 2461576 2461577 2461578 2461579 2461580 2461581 2461582 2461583 2461584 2461585 2702426 2933269 3053518 3053546 3053554  4046090001 7117840001 7117850001 6359420001 6404150001 6422990001 6464740001 7117860001 "05.1587814 05.1438412 05.1521913

Orthopedic Devices

1

No

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

Torque Limiting Screwdriver: || Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. || PRECIMED, Non Sterile. || Zimmer, Non Sterile, Rx Only. || Screwdriver: || Customer Number/Model: || 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

6307760001

Orthopedic Devices

1

No

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

Torque Limiting Handle: || PRECIMED, T-Handle Torque, Non Sterile. || Handle: || Customer Number/Model: || MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, || TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, || TLT911-35-S01 TLT911-35-S01.

Lot Number: W3101005

Cardiovascular Devices

2

No

NY

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W3363851, W3370052, W3374699, W3374700, W3379647, W3379650, W3384700, W3384701, W3390549, W3390551, W3397877, W3397879, W3397950, W3407814, W3407815, W3436351, W3436355, W3436356, W3436358, W3441735, W3441737, W3446767, W3446769, W3449392, W3451862, W3451863, W3455438,  W3455439, W3455440, W3459354, W3462467, W3462470, W3470335,  W3470336, W3483637, W3493240, W3497507, W3501348, W3501349,  W3581648, X3489776, X3497121, X3497510, X3501344, X3501345, X3503248,  X3507599, X3514814, X3518116, X3565743, X3581652, X3586059, X3592497.   Model D140011, Lots:

Cardiovascular Devices

2

No

CA

Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). || The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.

Cardiovascular Devices

2

No

Worldwide Distribution: United States, including the states of MN and CA.

Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.

Lot no.: W2046680, W2046681, W2072907, W2078460, W2084872, W2098770, W2098771, W2102124, W2102128, W2102133, W2102134, W2108295, W2108296, W2108298, W2108299, W2108300, W2125688, W2125690, W2132584, W2132588, W2132590, W2138965, W2143146, W2143147, W2143149, W2143152, W2145645, W2145677, W2145680, W2145681, W2151287, W2151305, W2151308, W2156746, W2156748, W2156750, W2156751, W2162494, W2162496, W2162497, W2162498, W2162499, W2167985, W2167986, W2167987, W2167988, W2167990, W2172705, W2172706, W2172707, W2172708, W2172710, W2172712, W2177727, W2177728, W2177729, W2177730, W2177733, W2177734, W2184476, W2184483, W2184484, W2184485, W2184487, W2184489, W2190457, W2190461, W2190462, W2190464, W2190470, W2196349, W2196351, W2196352, W2196355, W2196359, W2196361, W2196363, W2211842, W2211844, W2211846, W2211849, W2211850, W2211851, W2211852, W2211853, W2213887, W2213890, W2213892, W2213896, W2213898, W2213901, W2213982, W2221631, W2222017, W2222020, W2222022, W2222024, W2222027, W2222030, W2224408, W2224412, W2224417, W2224421, W2224423, W2224433, W2229959, W2229960, W2229961, W2229963, W2229965, W2229973, W2229974, W2236558, W2236561, W2236588.

Cardiovascular Devices

2

No

Nationwide distribution: CA only.

Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.

W1190519 W1190532 W1190532 W1190514 W1190517 W1190517 W1190516 W1266849 W1266851 W1266850 W1266848 W1298418 W1300005 W1298419 W1298425 W1298426 W1362771 W1362772 W1362773 W1362775 W1383678 W1362774 W1420240 W1420241 W1420242 W1434887 W1434888 W1464513 W1464514 W1464516 W1464511 W1464512 W1464515 W1466090 W1466092 W1466093 W1466091 W1467421 W1477933 W1467420 W1477935 W1477932 W1477934 W1490379 W1477937 W1490378 W1490380 W1490377 W1477936 W1509174 W1509175 W1532502 W1532501 W1509173 W1599234 W1629461 W1661254 W1688745 W1720426 W1746962 W1720428 W1792523 W1786461 W1788967 W1770099 W1807382 W1807383 W1807378 W1872468 W1872469 W1872470 W1927797 W1872468 W1927798 W1927799 W1963380 W2012849 W2012851 W2012850 W2047027 W2058073 W2047028 W2073401 W2047030 W2047031 W2094903 W2110798 W2170053 W2155950 W2170050 W2170052 W2192990 W2211695 W2211696 W2211697 W2268277 W2268271 W2315849 W2315850 W2315845 W2315846 W2315848 W2357893 W2357894 W2371770 W2371771 W2392043 W2357895 W2357896 W2397846 W2371772 W2386295 W2451688 W2451690 W2451691 W2451692 W2451693 W2461057 W2461056 W2461058 W2513845 W2561761 W2561762

Cardiovascular Devices

2

No

US Nationwide Distribution in the state of UT.

Coaxial Micro-Introducer Kit. || Greatbatch Part Number/Bard Access Systems Order Number/Part Description || 10636-001 || 8004011 || Kit Coax 10 Pack 4FR Bard || 10636-002 || 8005011 || Kit Coax 10 Pack 5FR Bard || 10636-007 || 8004012 || Kit Coax 10 Pack 4FR Bard || 10636-008 || 8005012 || Kit Coax 10 Pack 5FR Bard || 10636-009 || 8004022 || Kit Coax 10 Pack 5FR Bard || 10636-010 || 8005022 || Kit Coax 10 Pack 5FR Bard || The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

LOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588.

Cardiovascular Devices

2

No

Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA

Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

All lots

Orthopedic Devices

1

No

Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.

45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. || Model #: || P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. || The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

Manufacturing Lot : W18499722

Cardiovascular Devices

2

No

Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.

Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. || Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.

all lots

Orthopedic Devices

1

No

Worldwide Distribution - USA including CA, IN, KS, MA, NJ, TN,TX,UT and Internationally to Australia, Austria, Belgium, China, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117, T16427, T16604, T16611, T16661, T16829, T16934, T17062, T17203, T17238, T17321, T6318, T7821, T8042, T8043, T8044, T8087, T8088, T8093, T8095, T8177, T8184, T8277, T8310, T8333, T8468, T8487, T9109, T9196, T9205, T9316, T9348, T9360, T9556, T9557, T9747, T9894, T9954, T9955, T9999. || The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). || EXPANDED 3-28-2014: The following Part Numbers are also affected: P10270, P6427, P6464, P6501, P7611, P7640, P7794, P7927, P8233, P8590, T10006, T10261, T10606, T10835, T11095, T11506, T11622, T12081, T12083, T12124, T12125, T13435, T13527, T14174, T15262, T15515, T16418, T16551, T16552, T16553, T17272, T5709, T6744, T7751, T9195.

Class III

Disposable products

Reusable Products

Reusable Products

Reusable Products

Reusable Products

Disposable products