SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

Cooper Surgical 2 MHZ Waterproof OB Probe || Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

Article #9207010 Transformer (The transformer can be found as an individual item shipped with the products listed below) a) 57018W Kit PNSA W/O Bat PK WIC b) 57027 Kit PNSA Shoulder Bag c) 57027-03 Kit PNSA Shoulder Bag CS/3 d) 57027POP Display PNSA e) 57027T Kit PNSA w/Battery Pack f) 57036 Kit PNSA Metro g) 57036-03 Kit PNSA Black Metro h) 57036T 57036-03 Metro Tagged i) 57038 Pump ADV POP Medical Ast. j) 57043 57043 PNSA Without Kit k) 57045W Kit PNSA W/BAT PK WIC l) 57045WT KIT PNSA WIC W/BAT PK m) 57046 PNSA Tote without Kit n) 57062 Kit PNSA Backpack o) 57062-03 Kit PNSA Backpack CAl3 p) 57062T Kit PNSA Tagged Backpack q) 57063 PNSA Tote r) 57063-03 PNSA Tote 3-Pack s) 57063T PNSA Tote Tagged t) 6007113 Kit Motor Replacement Metro 2008

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - Nationwide Distribution and Puerto Rico and countries of Canada, Bermuda, Cayman Islands, Hong Kong and Haiti. CHI-DO proposes phone call audit checks of 2 consumers, 2 retailers and 1 hospital account by each district.

AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. || Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.

Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam

Affinity Four Birthing Bed P3700 || Product Usage: || The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.

Serial Number: C2386DA70E C2386EC9CD C2386ECAF3 C2386EC9CE C2386EC9B6  C2386EC9C5  C2386EC9C0  C2386EC9CB  C2386DA70D  C2386EC9AF  C2386EC9B7  C2386EC9CF  C2386EC9B4  C2386DA718  C2386ECAF5  C2386EC9B5  C2387684D9  C2386DA771  C2386EC9B8  C2386EC9D4  C2386EC9C3  C2386EC9B3  C2386ECAFA  C2386EC4C4  C2386EC9C9  C2386EC9D3  C2386ECAE6  C2386DA77E  C2386EC9B1  C2386DA715  C2386EC9CE  C2386EC9BC  C2386ECB36  C2386EC9C1  C2386EC9DC  C2386ECAF8  C2386DA786  C2386ECAFB  C2386EC9AE  C2386EC9C8  C2386EC9D0  C2386ECAEE

Obstetrical and Gynecological Devices

2

No

U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.

AirStrip Sense4Baby Model C Fetal Monitor || The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.

System Serial Numbers: FA002021 FA002022 FA002025 FA002027 FA002033 FA002020 FA002029 FA002005 FA002041 FA002044 FA002046 FA002112 FA002097 FA002117 FA002028 FA002047 FA002048 FA002118 FA002034 FA002093 FA002095 FA002116 FA002008 FA002023 FA002030 FA002031 FA002009 FA002098 FA002040 FA002092 FA002024 FA002114 FA002113 FA002115 FA002026 FA002032 FA001328

Obstetrical and Gynecological Devices

2

No

CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia

FETALGARD Lite Fetal Monitors, Model AP1S || (Single Fetus Monitoring)

Serial Numbers: FA002010 FA002051 FA002054 FA002059 FA002061  FA002062  FA002064  FA002011  FA002013  FA002014 FA002056 FA002065 FA002058

Obstetrical and Gynecological Devices

2

No

CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia

FETALGARD Lite Fetal Monitors, Model HCS || (Home Care Single Fetus Monitoring)

Trocars are assembled into procedure kits. Trocars have thier own serial number but the kit lots are relevant and include:  45036301001 to 45036301007 containing 1 each of lot 126803 = 71 each; 45208001001 to 452084001008 containing 1 each of lot 127322=8 each; 452451005001 to 452451005003 containing 1 each of lot 127322=3 each; 453029001001 to 453029001017 containing 1 each of lot 127322 = 17 each; 453715004002 containing 1 each of lot 126803 = 1 each; 454116005001 to 454116005002 containing 1 each of lot 127322 = 2; 454608003001 to 454608003006 containing 1 each of lot 172528 = 6 each.

Obstetrical and Gynecological Devices

2

No

Nationwide. Ireland.

Applied Blunt Tip Trocar || Models C0717 and C0718

All serial numbers involved

Obstetrical and Gynecological Devices

2

No

Distribution was to 44 medical facilities/hospitals nationwide.

BirthNet OB Data Management System 91861

1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex Medical Product Name: CLAMP MOGEN; Teleflex Medical Item Number: P-16310; Lot Numbers: 010214, 030113, 050114, 060313, 100112.   2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments Item Number: 46-5190; Lot Numbers: 030113, 100112.   3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical Item Number: 0-64227; Lot Numbers: 010214, 030112, 030113, 100112, 120413.   4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments Item Number: 185-6550; Lot Number: 080111.   5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical Item Number: 85-6550; Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413.   6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL Item Number: H156-7312; Lot Numbers: 010214, 030113.   7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion Item Number: VM57-6201; Lot Numbers: 010214, 030113, 050114, 080111, 100112.   8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp, infant; Teleflex MedicalItem Number: P-16310; Lot Number: 120111.

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.

Material Product Description Catalog # Batch Numbers Expiry Date  Matrix2¿ 2D Standard SR Coils 11286278,11535148,11975068,11975079, Oct2010 through  M003470103SRO 470103-SR 11985922,12156355,12156606,12176009,   10mm x30cm 12330517,12356322,12392934,13602979 Jun2013  M003470308SRO Matrix2¿ 2D Standard SR Coils 470308-SR 11766418,11775113 May2011 through   3mm x8cm May2011   Matrix2¿ 2D Standard SR Coils 11423155,11766419,11836539,11963593, Dec2010 through  M003470410SRO 470410-SR 12156359,12176012,12260125,12358023,   4mm x 10cm 12792923, 13705207 Jul2013  M003470510SRO Matrix2¿ 2D Standard SR Coils 470510-SR 12246984 Nov2011   5mmx10cm   Matrix2¿ 2D Standard SR Coils 11344392,11697463,11873433,11967353, Nov2010 through  M003470515SRO 470515-SR 12156357, 12156624, 12176010, 12259384,   5mmx15cm 12368756,12469532 Feb2012  M003470610SRO Matrix2¿ 2D Standard SR Coils 470610-SR 11800373,12520967 May2011 through   6mmx10cm Mar2012  M003470615SRO Matrix2¿ 2D Standard SR Coils 470615-SR 11377053,11985920,13201010,13220262 Dec2010 through   6mmx15cm Dec2012   Matrix2¿ 20 Standard SR Coils 11414852,11869799,11925610,11967354, Dec2010 through  M003470620SRO 470620-SR 12156352,12156602,12156627,12176016,   6mm x20cm 12261954, 12359026, 13015863, 13115971 Nov2012  M003470715SRO Matrix2¿ 2D Standard SR Coils 470715-SR 11622085,12379812,12853030 Mar2011 through   7mm x 15cm Jul2012  M003470720SRO Matrix2¿ 2D Standard SR Coils 470720-SR 11800378,11984852,13201011,13220457 May2011 through   7mm x20cm Oec2012   Matrix2¿ 2D Standard SR Coils 11869790,11925609,11940380,11992208, Jun2011 through  .J1003470730SRO 470730-SR 12156353,12156605,12176081,12176125,   7mm x30cm 12261953,12311506 Dec2011  M003470820SRO Matrix2¿ 2D Standard SR Coils 470820-SR 11248568,11946183,13201012 Oct2010 through   8mm x20cm Dec2012   Matrix2¿ 2D Standard SR Coils 11552555, 11925611, 11940382, 11975162, Feb2011 through  M003470830SRO 470830-SR 12176014,12261957,12316891,12361241,   8mm x 30cm 12401291 Jan2012  M003470920SRO Matrix2¿ 2D Standard SR Coils 470920-SR 13602873   9mm x20cm Jun2013   Matrix2¿ 2D Standard SR Coils 11869791, 11925176, 11975070, 11975185, Jun2011 through  M003470930SRO 470930-SR 12156358,12156615,12176011,12261956,   9mm x30cm 12370630 Jan2012

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch numbers Expiry Date    Matrix2¿ 360 Firm Coils 1 Omm x 11252548,11403351,11513899,11552537, Oct2010 through  M0034941 030 494103 11640881,12009568,12102561,12229607,   30cm 12365838, 12366382 Jan2012  M0034941230 Matrix2¿ 360 Firm Coils 12mm x 494123 11560338,11766417,11782395,11925586, Feb2011 through   30cm 12026743, 12316656, 12636596 Apr2012   11244766,11336915,11456769,11484774,  M0034941430 Matrix2¿ 360 Firm Coils 14mm x 494143 11526777, 11766660, 11850791, 11958233, Oct2010 through   30cm 11958454,12317003,12396265,12753164, Jan2013   13165081,13182077,13230095   11253266,11336717,11454608,11489048,  M0034941630 Matrix2¿ 360 Firm Coils 16mm x 494163 11526778,11697444,11697471,11958444, Oct2010 through   30cm 12176133,12214864,12319343,12396264, Dec2012   12859706, 13194482   11385269,11389724,11454839,11498643,  M0034941 830 Matrix2¿ 360 Firm Coils 18mm x 494183 11609723,11766661,11869780,11958440, Dec2010 through   30cm 12036898,12225706,12316657,12365837, Aug2012   12396263, 12854017, 12929266   Matrix2¿ 360 Firm Coils 20mm x 11330476,11483884,11526779,11697442, Nov2010 through  M0034942030 494203 11766414,11766673,11958234,11999799,   30cm 12194742,12317006,12753163,12859707 Jul2012   11252232,11380482,11551322,11785187,   11785188,11785190,11785191,11785192,  M0034942440 Matrix2¿ 360 Firm Coils 24mm x 494244 11785193,11785194,11785195,11813607, Oct2010 through   40cm 11813608,11813609,11813610,11850841, Jul2012   12176108,12316654,12395388,12395420,   12428559,12429040,12841941,12861721  M0034945150 Matrix2¿ 360 Firm Coils 5mm x 494515 12214867,12636725 Oct2011 through   15cm Apr2012  M00349461 50 Matrix2¿ 360 Firm Coils 6mm x 494615 11340651,11474492,11958445 Nov2010 through   15cm Jul2011  M0034947200 Matrix2¿ 360 Firm Coils 7mm x 494720 11338767,11697459 Nov2010 through   20cm Apr2011  M0034948300 Matrix2¿ 360 Firm Coils 8mm x 494830 11488191,11850853,12000340 Jan2011 through   30cm Aug2011  M0034949300 Matrix2¿ 360 Firm Coils 9mm x 494930 11327025,11697448,11838298,11958230, Nov2010 through   30cm 12365839,12367860 Jan2012

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch numbers Expiry Date    11327721,11504445,11552548,11598084,   Matrix2 360 Soft SR Coils 3mm 11658821,11992209,12061946,12074034, Nov2010 through  M003490304SRO 490304-SR 12142090,12194733,12229550,12260121,   x4cm 12439221,12514518,12570927,12579017, Aug2012   12792914, 12899133   11249858,11314331,11340645,11474490,   11552544,11598080,11658789,11712104,   11730236,11748424,11829804,11850851,   11889315,11924291,11958451,11991899,   11992200,12009564,12061951,12067387,   12074300,12119830,12119908,12142037,   Matrix2 360 Soft SR Coils 3mm 12186121,12194487,12194492,12194709, Oct2010 through  ,1003490306SRO 490306-SR 12194729,12214847,12229676,12291688,   x6cm 12311954,12315364,12317008,12404354, Dec2012   12431055,12439440,12465571,12514602,   12636739,12670100,12698231,12721495,   12748470,12792883,12810371,12856503,   12861688,12874522,12922027,12929077,   12982322,13164432,13164796,13165110,   13204836   11391994,11451245,11497223,11560544,   11622024,11697452,11697465,11730229,   11790203,11820285,11889311,12009567,   12009651,12043116,12061789,12067386,   12074308,12119826,12119905,12141858,   12142023,12142080,12194713,12194748,  M003490308SRO Matrix2 360 Soft SR Coils 3mm 490308-SR 12229543,12229557,12291689,12311955, Dec2010 through   x8cm 12388033,12401320,12418209,12514601, Aug2013   12549500,12549515,12579001,12579011,   12636731,12669965,12669977,12695189,   12698227,12748429,12783352,12792903,   12861733,12878386,12922007,12947549,   12982323,12982331,13108353,13165103,   13611875,13740715   11248431,11435810,11488182,11538866,   11560545,11580674,11586995,11790201,   11820178,11850847,11873431,11925605,   11940385, 11975165, 11975196, 11992221,   12043112,12102495,12102570,12130816,   Matrix2 360 Soft SR Coils 4mm 12141856,12142021,12156618,12176087, Oct2010 through  M003490406SRO 490406-SR 12176123,12214854,12267374,12320493,   x6cm 12324045,12330630,12358025,12376354, Dec2012   12401323, 12404357, 12427985, 12434604,   12446873,12579365,12589398,12636758,   12669962,12669976,12703153,12810347,   12861698,12903423,12922029,12947553,   13016331, 13165116   11293329,11378006,11388501,11399189,   11435809,11440484,11486119,11535146,   11552543,11560543,11597979,11622027,   11658787,11676144,11676159,11718824,   11873435,11889920,11908086,11958455,   11975069,11975169,11992215,12009576,   12009646,12026499,12043220,12061955,   12082847,12119839,12130814,12142089,   12156612,12156625,12175821,12176089,   12176103,12176120,12214807,12214856,   Matrix2 360 Soft SR Coils 4mm 12225445,12226291,12228156,12260124, Oct2010 through  M003490408SRO 490408-SR 12330661,12370631,12372625,12374139,   x8cm 12377446,12388031,12439195,12439232, Jun2013   12465567, 12474440, 12474444, 12495244,   12514511,12514582,12514604,12553672,   12567223, 12570928, 12582206, 12636730,   12636747, 12670043, 12688725, 12703180,   12753145,12753168,12792891,12792918,   12856252,12861683,12861699,12882522,   12909275,12922001,12947529,12947548,   12981235,12982325,12982333,13113667,   13164429,13165088,13165106,13204887,   13614550   11241568,11295953,11318655,11388824,   11418198,11418199,11516242,11552539,   11598087,11676147,11756825,11838296,   11838633,11869781,11889923,11925601,   11940383,11963587,11975076,11975177,   11992204, 11992211, 12009654, 12047550,   12102498,12102572,12112301,12127497,   12142022,12142032,12161233,12194719,  M003490510SRO Matrix2 360 Soft SR Coils 5mm 490510-SR 12194746,12210213,12228826,12229587, Oct2010 through   x 10cm 12330645, 12368750, 12370623, 12379815, Aug2013   12427984, 12434603, 12465569, 12495250,   12549419,12549506,12549519,12577901,   12579023,12669966,12669974,12698233,   12703157,12703197,12792900,12810352,   12859278, 12861729, 12902494, 12914299,   12921998, 12947534, 12982326, 12982334,   13016338,13026037,13115713,13165098,   13182062,13190678,13740723     11241926,11323157,11388508,11411633,   11472604,11497222,11497859,11552549,   11606463,11640894,11676145,11721432,   11756827,11820291,11850795,11869792,   11889924,11938493,11940586,11963588,   11967351,11975074,11975172,12000344,   12018387,12047344,12102497,12110476,   12112237,12127025,12142024,12142083,   12161228,12194730,12214802,12214859,  M003490515SRO Matrix2 360 Soft SR Coils 5mm 490515-SR 12229580,12260120,12300881,12306629, Oct2010 through   x 15cm 12315370,12325704,12330628,12358024, Dec2012   12388029,12392932,12404351,12404358,   12409148,12413361,12424871,12434608,   12439355,12579003,12632701,12669001,   12670051,12698225,12703147,12703181,   12721620,12721636,12792915,12810345,   12810362,12856010,12861695,12888522,   12909744,12920953, 12921984, 12922004,   12929263,12982271,13165090,13165119,   13182076   11299320,11329549,11340642,11489571,   11552541,11712108,11721431,11748391,   11869789,11908094,11963589,11967349,   11975170,12061949,12074316,12141375,   12156611,12169000,12176013,12176090,  M003490610SRO Matrix2 360 Soft SR Coils 6mm 490610-SR 12214809,12259818,12291684,12295456, Oct2010 through   x 10cm 12311956,12330632,12378758,12392930, Jan2013   12401019,12404355,12404521,12424874,   12431054,12431056,12434610,12579027,   12669978,12792895,12918642,12947544,   12982272,12990294,13016325,13113185,   13164431,13182075,13233311   11319664,11344931,11404790,11491182,   11535755, 11552536, 11591703, 11606465,   11658794,11676146,11766676,11800186,   11838299,11850782,11850790,11850850,   11889929,11924290,11934376,11975181,   11992205,12009572,12009647,12061952,   12067384,12074309,12074310,12119828,   12119837,12130808,12142039,12187530,  M003490615SRO Matrix2 360 Soft SR Coils 6mm 490615-SR 12194495,12194712,12194740,12214819, Nov2010 through   x 15cm 12299317,12299410,12306630,12315369, Sep2012   12356256,12358026,12401293,12404352,   12404356, 12413360, 12413362, 12424875,   12434602,12439442,12577739,12579015,   12632700,12669000,12670054,12703188,   12721627,12748472,12810341,12810348,   12838009, 12849284, 12860900, 12861724,   12903859,12906596,12921997,12922014,   12981467, 13015393, 13016327   Matrix2 360 Soft SR Coils 7mm 11396531,11552538,11766668,11992206, Dec2010 through  M003490710SRO 490710-SR 12074303, 12259819, 12370622, 12431053,   x 10cm 12964403 Aug2012     11247286,11330876,11399084,11520021,   11591598,11697443,11697461,11730232,   11756828,11916973,11991893,12026494,   12047549,12051396,12119832,12168018,   12188228,12194707,12194754,12214195,  M003490715SRO Matrix2 360 Soft SR Coils 7mm 490715-SR 12225279,12291685,12296703,12315365, Oct2010 through   x 15cm 12330625,12356320,12365840,12392933, Aug2013   12404522,12409149,12434607,12439356,   12549524,12579012,12636741,12670048,   12783355,12810342,12912905,12922030,   12982327,12982335,13182064,13202907,   13740724   11377048,11388828,11433319,11475013,   11491419,11497447,11560339,11697464,   11730226, 11748420, 11756830, 11829805,  M003490720SRO Matrix2 360 Soft SR Coils 7mm 490720-SR 11838635, 11908085, 11985698, 12102494, Dec2010 through   x20cm 12102565,12127495,12161470,12214855, Dec2012   12228403,12519871,12549526,12703220,   12791151,12792885,12917401,12982273,   13164433,13174305   11249122,11307527,11396327,11521506,   11552545,11622021,11712106,11748392,   11756831,11850798,11869806,11940395,   11963590,11975175,12018395,12061950,   12082824,12102573,12130175,12155990,  M003490820SRO Matrix2 360 Soft SR Coils 8mm 490820-SR 12176091,12176132,12214706,12214712, Oct2010 through   x20cm 12214848,12295450,12295454,12296712, Dec2012   12296713,12304194,12304198,12330636,   12358027,12364673,12474441,12514599,   12577900, 12636735, 12792882, 12922025,   12982274,13016323,13115792,13164434,   13182066   11342412,11475011,11504449,11543008,   11560541, 11658790, 11676153, 11790202,  M003490830SRO Matrix2 360 Soft SR Coils 8mm 490830-SR 11850783, 11850796,11946181,12047553, Nov2010 through   x30cm 12119902,12214863,12225442,12229613, Dec2012   12567225, 12636736,12906335,12947546,   13019231,13164435,13181899,13190677

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 360 Soft SR Coils. || Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch numbers Expiry Date    11322013,11341317,11395760,11407118,   11484317,11500845,11538872,11580676,   11586996,11591704,11676172,11786207,   11800707,11843132,11889308,11889310,   11924294, 11946182, 11975161, 11975197,   Matrix2¿ 360 Standard SR Coils 12000345,12119829,12127493,12156626, Nov2010 through  M003492103SRO 492103-SR 12176110, 12194735, 12214709, 12214800,   10mm x 30cm 12214853, 12229661, 12291690, 12299408, Jun2013   12315367,12330591,12409146,12418207,   12439180,12439189,12514594,12669964,   12670044,12703195,12791152,12792881,   12863906,12909368,12913888,12921982,   13165100,13182071,13602875   11296519,11329483,11422711,11477789,   11606464,11711221,11712103,11786210,   11908091,11924295,11940396,11975180,   11996498,12009649,12112236,12119825,   Matrix2¿ 360 Standard SR Coils 12141857,12156617,12214707,12214715, Oct2010 through  M003492123SRO 492123-SR 12214861,12291695,12295742,12314469,   12mm x 30cm 12392928,12401322,12458011,12462033, Jun2013   12519869, 12523479, 12669970, 12810344,   12861691,12912140,12920952,12921980,   12921996,12982276,13164798,13165084,   13603462   Matrix2¿ 360 Standard SR Coils 11286172,11327021,11552550,11756832, Oct2010 through  M003492308SRO 492308-SR 11792451,12082838,12194728,12494078,   3mm x8cm 12947522 Aug2012   11310925,11340517,11513571,11598083,   11748422,11820289,11850852,11924296,   11940398,11975077,12007427,12026497,   Matrix2¿ 360 Standard SR Coils 12026741,12074031,12074306,12110477, Oct2010 through  M003492408SRO 492408-SR 12130818,12142084,12156609,12176095,   4mm x8cm 12176129,12214851,12304396,12418211, Dec2012   12434605, 12439350, 12579013, 12702894,   12721623,12792899,12810370,12917824,   12947545, 13164799   11289583,11341604,11500842,11622022,  M003492510SRO Matrix2¿ 360 Standard SR Coils 492510-SR 11730241, 11786201, 11820321, 12194490, Oct2010 through   5mm x 10cm 12214705, 12434606, 12450913, 12465570, Aug2012   12922017   11299199,11318111,11389194,11500843,   11550742,11606466,11697460,11711220,   11748398,11838629,11889318,11916974,   11958443,11958463,11984850,12043111,   12061948,12082851,12086034,12142091,  M003492515SRO Matrix2¿ 360 Standard SR Coils 492515-SR 12150131,12176136,12188226,12194738, Oct2010 through   5mmx15cm 12214194,12225443,12229718,12330640, Aug2013   12361044,12378759,12383763,12431052,   12439197, 12636726, 12656660, 12792894,   12805887,12861538,12861680,12899138,   12921993,12922024,12929260,12982324,   13164797,13182067,13197169,13740709   Matrix2¿ 360 Standard SR Coils 11300189,11697441,11748423,12102562, Oct2010 through  M003492610SRO 492610-SR 12194744,12650932,13109926,13201013,   6mm x 10cm 13220484 Dec2012   11281622,11311916,11314681,11491189,   11521070, 11591707, 11676160, 11730225,   11766704,11838625,11934378,11958468,   11975166,11975191,11992203,11992212,   12009577,12009653,12082842,12130810,   Matrix2¿ 360 Standard SR Coils 12142036,12161320,12168019,12176126, Oct2010 through  M003492615SRO 492615-SR 12214841,12229589,12300888,12330615,   6mmx15cm 12379816, 12388035,12409150,12427992, Dec2012   12439353, 12519870, 12549504, 12549518,   12636727, 12670053, 12721624, 12748411,   12791149, 12792892, 12861690, 12889253,   12912271,12922000,12947541,12982277,   13016751,13165091   Matrix2¿ 360 Standard SR Coils 11311649,11552534,11697440,11697450, Oct2010 through  M003492715SRO 7mm x 15cm 492715-SR 11766703,12176124,12229551,12372622, Dec2012   12494180,12698228,12922016,13201014 11325958,11330877,11448223,11516241,   11591599, 11640896, 11676142, 11676149,   11766671, 11786209, 11795499, 11820176,   11868816,11925596,11975072,11975182,   11992202,11992218,12009562,12009570,  M003492720SRO Matrix2¿ 360 Standard SR Coils 492720-SR 12051397,12082854,12142030,12188227, Nov2010 through   7mm x20cm 12194711,12194747,12214845,12225440, Jul2013   12291691,12299412,12314471,12324046,   12355111,12401321,12409152,12418208,   12427990,12636754,12810346,12841940,   12861722, 12917822, 12922005, 12947520,   12947528, 13165089, 13705204   11303726, 11344541, 11491183, 11597978,   11697453,11730059,11766677,11800708,  M003492820SRO Matrix2¿ 360 Standard SR Coils 492820-SR 11836538,11838623,11958239,12043226, Oct2010 through   8mm x20cm 12130809,12194736,12260123,12388030, Jun2013   12669969, 12791148, 12792880, 12922002,   13201015, 13202909, 13606213   11310595,11410936,11470446,11552546,   11606467,11658788,11712109,11766665,   11800187,11838294,11869782,11925588,   11975179,11992216,12009571,12043110,   Matrix2¿ 360 Standard SR Coils 12061953, 12069212, 12074311, 12119903, Oct2010 through  M003492830SRO 492830-SR 12150137,12188230,12194489,12194704,   8mm x30cm 12229669, 12291686, 12296707, 12314472, Dec2012   12330585,12356257,12361056,12636753,   12669979, 12703142, 12753169, 12783354,   12792913, 12895634, 12899136, 12912676,   12922009,13165096  .,tl003492920SRO Matrix2¿ 360 Standard SR Coils 492920-SR 11318113,11441724,11542877,11711222, Nov2010 through   9mm x20cm 11838626,12150132,12579018,13614169 Jun2013   11290201,11318378,11403946,11488185,   11520165,11598081,11658797,11748390,   11889313,11940587,11952858,12009643,   12026498,12061945,12069211,12074037,   Matrix2¿ 360 Standard SR Coils 12130804,12176121,12194485,12194498, Oct2010 through  M003492930SRO 492930-SR 12194734,12229597,12295451,12296708,   9mm x 30cm 12325703,12355110,12549418,12549503, Aug2013   12564285,12579005,12589397,12656661,   12669971,12792539,12792897,12853506,   12861697,12891631,12922012,12982278,   13182063, 13204832, 13740457 .

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch Numbers Expiry Date   M003471304SRO Matrix2¿ 2D Soft SR Coils 3mm 471304-SR 11391991,11697446,11721433,11775115, Dec2010 through   x4cm 12579020 Mar2012  M003471306SRO Matrix2¿ 2D Soft SR Coils 3mm 471306-SR 11498868,11775116,12194493,12385403, Jan2011 through   x6cm 12520966, 12861735 Jul2012  M003471308SRO Matrix2¿ 2D Soft SR Coils 3mm 471308-SR 11481348,11792449,11820171,12401292, Jan2011 through   x8cm 12514514, 12792920 Jun2012  M003471310SRO Matrix2¿ 2D Soft SR Coils 3mm 471310-SR 11342011,11634830,12390151,12439220, Nov2010 through   x 10cm 12982264 Sep2012  M003471406SRO Matrix2¿ 2D Soft SR Coils 4mm 471406-SR 11502704,11641203,12081496,12474445, Jan2011 through   x6cm 12795286 Jun2012   11622088,11718835,11869785,11925599,   11940238,11985921,11992220,12156354,  M003471408SRO Matrix2¿ 2D Soft SR Coils 4mm 471408-SR 12156603,12176007,12176017,12194725, Mar2011 through   x8cm 12295449,12356324,12356325,12514591, Dec2012   12636738,12748405,12748465,12845925,   12891630,12906595,13200124   Matrix2¿ 2D Soft SR Coils 4mm 11310206,11552557,11766672,12119904, Oct2010 through  M003471410SRO 471410-SR 12161473,12409142,12439231,12791147,   x 10cm 12792538 Jun2012  M003471508SRO Matrix2¿ 2D Soft SR Coils 5mm 471508-SR 11622083,12176098,12229542,12721621, Mar2011 through   x8cm 13020445 Sep2012   11800192,11869788,11925606,11940381,   11963592,11996801,12155987,12156601,  M003471510SRO Matrix2¿ 2D Soft SR Coils 5mm 471510-SR 12176008,12194708,12314468,12330568, May2011 through   x 10cm 12368755,12409141,12514589,12636752, Jun2013   12669963,12670049,12703140,12753166,   12792908,12861687,12981682,13603463  M003471515SRO Matrix2¿ 2D Soft SR Coils 5mm 471515-SR 11384554,11641206,12176118,12182654, Dec2010 through   x 15cm 12246986,12649894,13020067 Sep2012   11384857,11748388,11925177,11940389,  M003471610SRO Matrix2¿ 2D Soft SR Coils 6mm 471610-SR 11967352,12112307,12155988,12176015, Dec2010 through   x 10cm 12330561,12356327,12374220,12847321, Aug2012   12947525,12971457  M003471615SRO Matrix2¿ 2D Soft SR Coils 6mm 471615-SR 11532410,11800196 Feb2011 through   x 15cm May2011  1003471620SRO Matrix2¿ 2D Soft SR Coils 6mm 471620-SR 11373732,11634833,12261958,12649895, Dec2010 through   x20cm 12792911 Jun2012  M003471710SRO Matrix2¿ 2D Soft SR Coils 7mm 471710-SR 12499178,13108359 Feb2012 through   x 10cm Oct2012  M003471715SRO Matrix2¿ 2D Soft SR Coils 7mm 471715-SR 11820280,12229546,12249163 May2011 through   x 15cm Nov2011  M003471720SRO Matrix2¿ 2D Soft SR Coils 7mm 471720-SR 11622084,11938494,12246985,12579366 Mar2011 through   x20cm Mar2012  M003471820SRO Matrix2¿ 2D Soft SR Coils 8mm 471820-SR 11622082,11766666 Mar2011 through   x20cm May2011  M003471830SRO Matrix2¿ 2D Soft SR Coils 8mm 471830-SR 11697466,12229584 Apr2011 through   x30cm Nov2011

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch Numbers Expiry Date   M003480 1030 Matrix2¿ Firm 2D 10mm X 30cm 4801030 11253687,11766663 Oct2010 through   10mm X 30cm May2011  M0034801230 Matrix2¿ Firm 2D 12mm X 30cm 4801230 11766667,12707248 May2011 through   12mm X 30cm May2012  M0034801430 Matrix2¿ Firm 2D 14mm X 30cm 4801430 11697099 Apr2011   14mm X 30cm  M0034801630 Matrix2¿ Firm 20 16mm X 30cm 480163 11426183,11766662 Dec2010 through   16mm X 30cm May2011  M0034801830 Matrix2¿ Firm 20 18mm X 30cm 4801830 11411206 Dec2010   18mm X 30cm  M0034802030 Matrix2¿ Firm 20 20mm X 30cm 480203 11777398 May2011   20mm X 30cm  M0034805150 Matrix2¿ Firm 20 5mm X 15cm 480515 11777399 May2011   5mm X 15cm  M0034806150 Matrix2¿ Firm 20 6mm X 15cm 480615 11757096 Apr2011   6mm X 15cm  M0034807200 Matrix2¿ Firm 20 7mm X 20cm 480720 11748387,12365836 Apr2011 through   7mm X20cm Jan2012  M0034808300 Matrix2¿ Firm 20 8mm X 30cm 480830 11297219,11991894,12365835 Oct2010 through   8mm X30cm Jan2012  M0034809300 Matrix2¿ Firm 20 9mm X 30cm 480930 11411626,11622081,12365834 Dec2010 through   9mm X30cm Jan2012

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch Numbers Expiry Date  M003471204SRO Matrix2¿ Helical Soft SR Coils 471204-SR 11297523,12469527 Oct2010 through   2mm x4cm Feb2012  M003471206SRO Matrix2¿ Helical Soft SR Coils 471206-SR 11422256,11697451,11952856,12361059 Dec2010 through   2mm x6cm Dec2011  M003471208SRO Matrix2¿ Helical Soft SR Coils 471208-SR 11389025,11552556,12514612,13606645 Dec2010 through   2mm x8cm Jun2013

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch numbers Expiry Date    11248651, 11291053, 11310207, 11323633,   11324250, 11385087, 11407756, 11410972,   11422254,11448538,11485969,11498926,   11505015,11531494,11550740,11552553,   11552580,11597969,11606471,11606472,   11676141,11676143,11676154,11676161,   11676175, 11730058, 11730228, 11730244,   11748054, 11800191, 11820286, 11838627,   11889317,11924292,11958237,11958446,   11958453,11958471,11975195,11988267,   12000346, 12008847, 12009650, 12018903,   12043119,12061957,12082823,12082831,   12082850,12102560,12102569,12112304,   12112308,12119827,12119836,12119901,   12130250, 12142092,12156613,12156623,   12161471,12176094,12176106,12176116,  M003497202SRO Matrix2¿ Helical UltraSoft SR 497202-SR 12176127,12194710,12194727,12194750, Oct2010 through   Coils 2mm x 2cm 12218091,12229544,12229549,12229554, Jun2013   12229582,12229588,12370629,12370632,   12378756,12379811,12379813,12413136,   12424868,12431048,12434612,12439198,   12439223,12468833,12495249,12514510,   12514517,12514583,12514600,12541586,   12549501,12549505,12549508,12549516,   12567226,12577905,12579009,12636525,   12636595,12636597,12636599,12636721,   12636734, 12659325, 12659332, 12703186,   12721622, 12721629, 12745887, 12748430,   12786766, 12792889,12792902,12810349,   12810366, 12841849, 12841850, 12841852,   12849196, 12861693, 12861725, 12891431,   12891438, 12914154, 12947533, 12947547,   12986455,13016337,13165099,13165118,   13194022, 13606643, 13606644   11285639, 11337201, 11373711, 11392488,   11395916,11445479,11472230,11494690,   11497220,11535565,11552559,11552581,   11639657,11676156,11788747,11850784,   11850797,11925583,11946186,11958478,   11975189,11996499,12008848,12018900,   12051398,12082825,12082840,12082861,   12112238,12119833,12127027,12149738,   12156620,12176104,12176119,12194716,  M003497203SRO Matrix2¿ Helical UltraSoft SR 497203-SR 12194726,12194752,12229548,12229596, Oct2010 through   Coils 2mm x 3cm 12306628,12320490,12359522,12361245, Jun2013   12396159,12409144,12418204,12424870,   12439224,12465526,12495252,12514506,   12514515,12514590,12521676,12567229,   12579025,12636729,12636751,12669006,   12674065,12703141,12703159,12703194,   12721499,12721630,12792887,12792906,   12792964,12861731,12895492,12903293,   12917355,12981468,13009557,13165104,   13204891,13608890   11287783,11300979,11319984,11432669,   11433113,11494689,11495753,11552552,   11597970,11634832,11676155,11712107,   11747856,11748041,11800376,11820294,   11850787,11850845,11925179,11925604,   11940589,11952667,11975171,12000343,   12018378,12018901,12047551,12069209,   12074315, 12119824, 12119831, 12119909,   12142085,12161472,12165272,12176115,   Matrix2¿ Helical UltraSoft SR 12194705,12194732,12228152,12258932, Oct2010 through  .J1003497204SRO 497204-SR 12299402,12330600,12359521,12392935,   Coils 2mm x 4cm 12396260,12409145,12413137,12418203, Jun2013   12424876,12434613,12491075,12514508,   12514580,12514606,12521678,12578758,   12579000,12579006,12579014,12669975,   12702895,12703144,12703149,12721633,   12745888,12748426,12792907,12810358,   12841853,12841854,12841855,12841856,   12856504,12861689,12861730,12899758,   12917356,12922023,12968201,12981315,   12982266,13016333,13606211   11289497,11384552,11425586,11550741,   11597972, 11606469, 11676171, 11717889,   11820290,11838641,11925603,11940387,   11958450, 11975190, 11988269, 12007430,   12047552,12112300,12119900,12130811,   12155989,12156622,12176084,12176100,   Matrix2¿ Helical UltraSoft SR 12176128,12194706,12194721,12228145, Oct2010 through  M003497206SRO 497206-SR 12229670,12300719,12361244,12370633, Coils 2mm x 6cm 12379814,12383762,12390150,12413134, Jun2013   12431051,12450911,12495254,12514519,   12514611,12559585,12636722,12636745,   12703146,12703192,12721631,12745886,   12783350,12792909,12845819,12861723,   12891437,12912266,12914288,12981912,   12982279,13194132,13608891     11287570,11345097,11415538,11502184,   Matrix2¿ Helical UltraSoft SR 11538868, 11588278, 11641201, 11718833, Oct2010 through  M003497208SRO 497208-SR 11838628,12007429,12229547,12299413,   Coils 2mm x 8cm 12434615,12520964,12579022, 12695190, Jun2013   12792912,12947542,12982320,13610848   Matrix2¿ Helical UltraSoft SR 11249332,11337880,11501859,11606470, Oct2010 through  M003497210SRO 497210-SR 11712100,11800700,12229558,12377448,   Coils 2mm x 10cm 12469866,12514598,12982267,13204828 Dec2012   11378010,11502182,11622090,11697455,  M003497215SRO Matrix2¿ Helical UltraSoft SR 497215-SR 11730220, 11786208, 12194494, 12214868, Dec2010 through   Coils 2mm x 15cm 12374370,12439193,12495251,12514512, Dec2012   12634402,12792904,12982268,13194285  M003497253SRO Matrix2¿ Helical UltraSoft SR 497253-SR 11766416,12514587,12702892,12841857, May2011 through   Coils 2.5mm x 3cm 13201016, 13221197 Dec2012  M003497254SRO Matrix2¿ Helical UltraSoft SR 497254-SR 11373706,11447829,11634829,11892358, Dec2010 through   Coils 2.5mm x 4cm 12194722,12748425,13165111,13201017 Dec2012  M003497256SRO Matrix2¿ Helical UltraSoft SR 497256-SR 11766415,11782389,11788748,12214843, May2011 through   Coils 2.5mm x 6cm 12377447,12383760,13201018,13233176 Jan2013   11378011,11560337,11634831,11748042,   11850799,11869795,11925581,11940585,   11952852,11975184,12026746,12061959,   12074301,12074302,12142034,12161321,   12165270,12194749,12229671,12241647,  M003497304SRO Matrix2¿ Helical UltraSoft SR 497304-SR 12246983,12358559,12368753, 12383679, Dec2010 through   Coils 3mm x 4cm 12388037, 12396261, 12418205, 12450912, Dec2012   12514509,12514605,12577902,12577910,   12634401,12659324,12692367,12702867,   12703156,12703199,12753183, 12786768,   12858818,12891629,12947531,12981683,   12999165,13204890   11286452,11327336,11408586,11444957,   11485583, 11531650, 11597971, 11800377,   11850785,11889927,11925598,11940588,   11958475,11996800,12004083,12026747,   12043117,12061981,12074038,12074039,   12112239,12142027,12156610,12176105,   12194484,12194488,12194496,12194714,   Matrix2¿ Helical UltraSoft SR 12214713,12214811,12306635,12359020, Oct2010 through  M003497306SRO 497306-SR 12365843,12378757,12385402,12390152,   Coils 3mm x 6cm 12392936,12423456,12431049,12468832, Dec2012   12469526,12495245,12514513,12514593,   12549502,12549510,12549527,12636598,   12669972,12670047,12702626,12721496,   12721625,12721639,12753187,12786767,   12792901,12810351,12861737,12895628,   12909841,12929079,12947535,12968747,   13165105   11285911,11374154,11415732,11495563,  M003497308SRO Matrix2¿ Helical UltraSoft SR 497308-SR 11526776, 11597973, 11838631, 11958464, Oct2010 through   Coils 3mm x 8cm 12004084,12051399,12359021,12523447, Jun2013   12579021,12912187,13165094,13611268   11289762,11327222,11430208,11538867,  M003497310SRO Matrix2¿ Helical UltraSoft SR 497310-SR 11580673,11711977,11748045,11792445, Oct2010 through   Coils 3mm x 10cm 11820293,12102566,12142029,12359022, Dec2012   12523446,12947537,13204827,13204892     11374084,11425585,11495750,11531651,   Matrix2¿ Helical UltraSoft SR 11552554,11622089,11712110,11795625, Dec2010 through  M003497315SRO 497315-SR 11800194,11984851,12004085,12194751,   Coils 3mm x 15cm 12514584,12559586,12636750,12779826, Dec2012   12903471, 13116656, 13165113   11377055,11426750,11477786,11505008,   11597975,11640819,11676158,11697457,   11697467,11718257,11719462,11748046,  M003497320SRO Matrix2¿ Helical UltraSoft SR 497320-SR 11958460,11959904,12007428,12018397, Dec2010 through   Coils 3mm x 20cm 12069208,12258931,12413138,12439181, Dec2012   12439194,12514507,12514595,12521677,   12636728,12753167,12792919,13165114,   13190676   11392486,11502702,11552558,11869786,   11934763,11952853,12009575,12021622,   Matrix2¿ Helical UltraSoft SR 12043108,12069207,12074305,12093266, Dec2010 through  M003497 406S RO 497406-SR 12110475, 12169001, 12214710, 12315368,   Coils 4mm x 6cm 12372621,12385406,12514581,12549507, Nov2012   12670040,12702893,12703191,12810350,   12841858,12929267,12947521,13118720   1.1292934,11380184,11447831,11597968,   11800195,11843131,11924293,11934379,   11938495,11963591,11992217,12043114,   12069206,12074032,12074307,12093267,   Matrix2¿ Helical UltraSoft SR 12161236,12176018,12176114,12306450, Oct2010 through  M003497408SRO 497408-SR 12330566,12359024,12385401,12390153,   Coils 4mm x 8cm 12392938,12431050,12514505,12514585, Dec2012   12521675,12636746,12669967,12670045,   12703143,12703196,12748434,12792254,   12792910,12841859,12899757,12947526,   12947554,13165109   11392633,11477710,11535147,11639656,  M003497410SRO Matrix2¿ Helical UltraSoft SR 497410-SR 11766700,11850786,11934764,12102568, Dec2010 through   Coils 4mm x 10cm 12165269,12374138,12514588,12912763, Aug2013   13165097,13204889,13569790,13740720   11374155,11403350,11444954,11484426,   Matrix2¿ Helical UltraSoft SR 11542681,11597974,11697474,11792447, Dec2010 through  M003497415SRO 497415-SR 11820179,12082862,12165271,12214844,   Coils 4mm x 15cm 12229556,12377449,12383761,12579008, Aug2012   12792916,12896408,12947540   11391872,11472233,11538871,11586993,   11697472,11785998,11800709,11820177,  M003497420SRO Matrix2¿ Helical UltraSoft SR 497420-SR 11850854,11934766,11958461,12000347, Dec2010 through   Coils 4mm x 20cm 12012195,12069205,12439228,12514608, Dec2012   12549511,12783351,12810354,12971787,   13182061  M003497510SRO Matrix2¿ Helical UltraSoft SR 497510-SR 11448920,11580671,11785997,11820169, Dec2010 through   Coils 5mm x 10cm 12229540,12439184,12965681 Aug2012  M003497515SRO Matrix2¿ Helical UltraSoft SR 497515-SR 11481347,11697449,11782386,11800703, Jan2011 through   Coils 5mm x 15cm 12142081,12182653,12377451,12586142 Mar2012   11287209,11329750,11474491,11500844,  M003497520SRO Matrix2¿ Helical UltraSoft SR 497520-SR 11634834,11838295,11850842,11958458, Oct2010 through   Coils 5mm x 20cm 12194739,12258930,12439185,12465527, Sep2012   12849285,12906594,12982321,12989985  M003497610SRO Matrix2¿ Helical UltraSoft SR 497610-SR 11415310,11494692,11697447,11747879 Dec2010 through   Coils 6mm x 10cm Apr2011  1003497615SRO Matrix2¿ Helical UltraSoft SR 497615-SR 11697445,11775114,12082856,12260480, Apr2011 through   Coils 6mm x 15cm 12947552 Aug2012     Matrix2¿ Helical UltraSoft SR 11422255,11480517,11597977,11868815, Dec2010 through  M003497620SRO 497620-SR 12119834,12142025,12182652,12494077,   Coils 6mm x 20cm 12791146,12792893,12982269,13165112 Dec2012

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 Helical UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch Numbers Expiry Date   M0034751030 Matrix2¿ 3D-Omega Standard 475103 13097570 Oct2012   Coils 1 Omm x 30cm  M0034753060 Matrix2¿ 3D-Omega Standard 475306 13204826 Dec2012   Coils 3mm x 6cm  M0034754060 Matrix2¿ 3D-Omega Standard 475406 13199749 Dec2012   Coils 4mm x 6cm  M0034755080 Matrix2¿ 3D-Omega Standard 475508 13204829 Dec2012   Coils 5mm x 8cm  M0034755100 Matrix2¿ 3D-Omega Standard 475510 13097571 Oct2012   Coils 5mm x 10cm

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Material Product Description Catalog # Batch numbers Expiry Date   11252230,11308509,11314276,11325957,   11336598, 11393159, 11395513, 11407112,   11451244,11531641,11550997,11560540,   11591562,11591706,11622023,11658783,   11658785,11658822,11676148,11676157,   11719463, 11730234, 11790200, 11800701,   11800705,11820288,11850793,11850843,   11873434,11908088,11934094,11958442,   11958449,11958467,11975078,11975174,   12018396,12061956,12082830,12093269,   12102499, 12102571, 12112302, 12119035,  M003498204SRO Matrix2¿ 360 UltraSoft SR Coils 498204-SR 12130177,12156608,12156619,12172635, Oct2010 through   2mm x4cm 12175697,12176083,12176088,12176096, Aug2013   12176113,12176130,12214865,12229603,   12229665,12229709,12300883,12304385,   12316893,12330638,12372623,12383765,   12388036,12498742,12514610,12549119,   12549517,12579004,12669973,12670052,   12702899,12703158,12721628,12748406,   12775526,12792905,12810367,12847198,   12856251,12861682,12861685,12861728,   12902495,12909257,12920788,12922010,   12922031,12947555,13165095,13182078,   13740728   11285904, 11325811, 11330308, 11336721,   11344686,11429308,11430218,11491190,   11535756,11551320,11580678,11586999,   11606468,11640887,11676151,11676165,   Matrix2¿ 360 UltraSoft SR Coils 11792442,11820281,11820295,11850792, Oct2010 through  M003498206SRO 498206-SR 11850844,12043227,12119036,12130803,   2mm x6cm 12130817,12194743,12229581,12229605, Jun2013   12299406,12304391,12514596,12549520,   12650936,12792884,12861539,12861681,   12861726,12929268,12947551,12982270,   13165082,13165102,13600453   11290821,11306854,11414844,11415101,   11488903,11524527,11535144,11598085,   11658796,11730211,11756822,11800379,   11850788,11873437,11889319,11889933,   11958235,11958447,11975073,11975199,   11992222,12009642,12043109,12082849,   12102496,12112306,12130249,12156604,   Matrix2¿ 360 UltraSoft SR Coils 12156607,12156621,12172961,12175696, Oct2010 through  M003498304SRO 498304-SR 12175827,12176080,12176086,12176101,   3mm x4cm 12229674,12229678,12304388,12315366, Jan2013   12330621,12368749,12370624,12374136,   12374221,12376353,12379817,12383766,   12514603,12541587,12549512,12549525,   12579028,12636755,12703154,12703190,   12748467,12792896,12861696,12902497,   12922003,12922028,12947530,13165085,   13165101,13198188,13204883,13230537    I 11302950,11385614,11385615,11403344,   11440497,11444540,11475012,11523684,   11552540,11591597,11598082,11622020,   11640889, 11676150, 11730057, 11730213,   11788744, 11820175, 11820292, 11836537,   11850840,11873438,11908089,11925597,   11958473,11975164,11975183,11992201,   12009563,12009573,12009640,12026744,   12043228, 12067385, 12082843, 12082859,   Matrix2¿ 360 UltraSoft SR Coils 12112303,12127498,12142026,12142038, Oct2010 through  M003498306SRO 498306-SR 12176131,12188229,12194499,12194715,   3mm x6cm 12194731,12214717,12214815,12214857, Aug2013   12229662, 12299405, 12304191, 12304196,   12368752,12388034,12396262,12418213,   12424869,12427988,12439191,12439351,   12549523,12636732,12636756,12670041,   12702896,12703155,12703187,12753182,   12783356,12792890,12792921,12858819,   12861684, 12861720, 12922011, 12929262,   13109928, 13165083, 13165093, 13606646,   13740721   11321963,11325815,11341602,11440812,   11444365, 11488901, 11489569, 11550743,   11560542, 11598086, 11658799, 11730230,   11788749,11820283,11850855,11916970,  M003498308SRO Matrix2¿ 360 UltraSoft SR Coils 498308-SR 11958232, 11958238, 11958448, 11958466, Nov2010 through   3mm x8cm 11996497,12102567,12130806,12194700, Jun2013   12194723,12214852,12229590,12549509,   12578759,12636733,12810343, 12885370,   12918062,12942555,12946179,13118674,   13165108,13182069,13600456   11293279,11318108,11345092,11407741,   11489572,11538865,11580677,11586997,   11658786,11712101,11719464,11789879,   11792443, 11820170, 11820282, 11850856,   11889925,11958236,11958456,12021661,   Matrix2¿ 360 UltraSoft SR Coils 12026495,12026742,12082848,12112305, Oct2010 through  M003498406SRO 498406-SR 12141859,12142033,12186120,12194702,   4mm x6cm 12194724, 12214850, 12229704, 12295452, Jun2013   12296704,12315362,12330599, 12439225,   12514516,12549514,12570929, 12669968,   12670046,12779824,12792888, 12805886,   12899134,12922013,12947538,13112464,   13165107,13610468 .   11314326,11320203,11336864,11396043,   11444147,11444545,11489567,11523682,   11538870, 11552547, 11560546, 11591708,   11658820,11676163,11676203,11788743,   11820174, 11820287, 11850846, 11873436,   11925602,11938492,11975160,11975176,   11975222,11992210,12009652,12061958,   12074313,12082844,12102564,12110478,   Matrix2¿ 360 UltraSoft SR Coils 12119835, 12130819, 12194486, 12194491, Oct2010 through  M003498408SRO 498408-SR 12194701,12194717,12194737,12214191,   4mm x8cm 12214718,12214817,12299414,12300716, Jun2013   12304387, 12330612, 12330647, 12385409,   12409147,12413139,12424873,12424877,   12439196, 12439352, 12567224, 12579029,   12669005, 12703185, 12721626, 12748407,   12783357,12791150,12922015,12929076,   12929261,12947543,12982329,12982336,   13116525,13164430,13165087,13182068,   13182074, 13602977   11321964, 11322842, 11432824, 11485038,   11531649, 11591564, 11591700, 11676177,   11697470,11712102,11719465,11721430,   11820323,11889309,11889316,11916971,   11952857,12026496,12043224,12061790,   12115320,12119907,12130813,12142087,  M003498510SRO Matrix2¿ 360 UltraSoft SR Coils 498510-SR 12194718,12214197,12214714,12214842, Nov2010 through   5mmx10cm 12267364, 12304383, 12311944, 12315361, Jun2013   12315363,12356259,12392931,12404359,   12418210, 12439358, 12549513, 12634217,   12703183,12748428,12791153,12792898,   12861694,12922006, 12929075, 13164428,   13164795,13165092,13195731,13200123,   13233310,13603121   11323634,11325812,11329547,11403547,   11552535,11591701,11711974,11711979,   Matrix2¿ 360 UltraSoft SR Coils 11766679, 11838297, 11850794, 11908093, Nov2010 through  M003498515SRO 498515-SR 11946180,11991286,12214846,12226292,   5mmx15cm 12229666,12306631,12446872,12468830, Oct2012   12495253,12514592,12523445, 12579019,   12810368,12914092,12946427,13113054   11281623, 11380106, 11552542, 11658791,   Matrix2¿ 360 UltraSoft SR Coils 11748395,11889312,12061947,12115321, Oct2010 through  M003498610SRO 498610-SR 12142031,12299316,12370621,12446874,   6mmx10cm 12514609,12632702,13118675,13165080, Aug2013   13740727   11322855, 11385261, 11486201, 11531652,   Matrix2¿ 360 UltraSoft SR Coils 11591702,11658823,11697473,11800199, Nov2010 through  M003498615SRO 498615-SR 12194497, 12214193, 12226290, 12229705,   6mmx15cm 12439187,12491070,12495248,12514597, Aug2013   12947527,12965255,13740729

Obstetrical and Gynecological Devices

1

No

Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

Model Catalog: CALM VERSION 2.9.1 (Lot serial: 02.09.01)

Obstetrical and Gynecological Devices

CALM Computer assisted labor monitoring

1) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm; CareFusion Item Number: VM29-7112; Lot Numbers: 07211, 100213.   2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21113; Trade Name: TeleFlex Medical; Teleflex Medical Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Teleflex Medical Item Number: VM29-7112; Lot Number: 100213.   3) Instrumed Product Name: Emmet Tenaculum Hook, #2, blunt; Instrumed Product Number: 310-21113; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #2, blunt; CareFusion Item Number: VM29-71131X; Lot Number: 110110.   4) Instrumed Product Name : Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Emmet Tenaculum Hook, #5; Symmetry Surgical Item Number: 20-4205; Lot Number: 050412.   5) Instrumed Product Name: Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #5; CareFusion Item Number: GL804-001; Lot Number: 030313.   6) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; CareFusion Item Number: VM29-7112X; Lot Numbers: 110312, 110411.   7) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: EMMETT HOOK QUICK RELEASE, NO 1, BLUE RF COATED; CareFusion Item Number: GL805; Lot Numbers: 010214, 020314, 110312.

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. || A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.

software version 6.80.0 only with Alert and Reminder feature activated

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution --- state of Ohio.

GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 || Intended for use as a clinical data management system.

software version 6.70.6 of the Centricity Perinatal clinical information system

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution --- including USA and country of Canada.

Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010

Lots 11224 and 06284.

Obstetrical and Gynecological Devices

2

No

Nationwide.

Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.

Lot 11224.

Obstetrical and Gynecological Devices

2

No

Nationwide.

Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.