Code:900548A Lots: 141015718 exp. 11/30/15 141216350 exp. 12/31/15 150116506 exp. 12/31/15 150116945 exp. 1/31/16 150116946 exp. 2/28/16 150318003 exp. 3/31/16 150318001 exp. 3/31/16 150318002 exp. 3/31/16 150418416 exp. 4/30/16 150418417 exp. 4/30/16 150518829 exp. 5/31/16 150518829 exp. 5/31/16 150619185 exp. 6/30/16 150619404 exp. 6/30/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

PERY-GYN SURGICAL PACK 6/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900635 Lots: 141015503 exp. 11/30/15 150116816 exp. 2/28/16 150116995 exp. 2/28/16 150318014 exp. 4/30/16 150318015 exp. 4/30/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

PERI GYN PACK 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900645 Lots: 141015504 exp. 11/30/15 150116817 exp. 2/28/16 150217475 exp. 2/28/16 150217476 exp. 2/28/16 150217477 exp. 2/28/16 150217478 exp. 3/31/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

O.B. PACK HOSPITAL 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900660 Lots: 141015724 exp. 10/31/15 150116818 exp. 1/31/16 150217433 exp. 1/31/16 150217434 exp. 1/31/16 150318123 exp. 3/31/16 150418262 exp. 4/30/16 150418263 exp. 4/30/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

CESAREAN PACK 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900851 Lots: 141015755 exp. 10/31/15 140915199 exp. 11/30/15 150318127 exp. 4/30/16 150318127 exp. 4/30/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

CESAREAN PK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code: 900921A Lots: 141015499 exp. 3/31/16 141216451 exp. 1/31/16 141216364 exp. 12/31/15 150317861 exp. 3/31/16 150317860 exp. 3/31/16 150418472 exp. 4/30/16 150418473 exp. 4/30/16 150518583 exp. 5/31/16 150518584 exp. 5/31/16 150518913 exp. 5/31/16 150619191 exp. 6/30/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

C-SECTION SURGICAL PACK 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Code: 900997 Lots: 141015748 exp. 10/31/15 150116983 exp. 1/31/16 150518852 exp. 5/31/16 150317855 exp. 5/31/16 150619300 exp. 6/30/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

PERI GYN PACK 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Code: 900998 Lots: 141015749 exp. 10/31/15 141015749 exp. 10/31/15 140915186 exp. 11/30/15 150116835 exp. 3/31/16 150317856 exp. 3/31/16 150317857 exp. 3/31/16 150518853 exp. 5/31/16

Obstetrical and Gynecological Devices

2

No

Distributed Only in Puerto Rico.

C-SECTION PK 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Manufacturing lot 1214-F-403 and 1214-V-424

Obstetrical and Gynecological Devices

2

No

Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. || Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

Serial numbers 622483, 622523, 622553, 622566, 622568, 622569, 622573, 622576, 622614, 622615, 622616, 622617, 622618, 622619, 622620, 622632, 622643, 622644, 622645, 622646, 622647, 622654, 622655, 622656, 622657, 622658, 622664, 622666, 622667, 622687, 622688, 622693, 622704, 622705, 622706, 622710, 622711, 622712, 622718, 622719, 622720, 622722, 622723, 622750, 622753, 622764, 622766, 622767, 622769, 622771, 622773, 622775, 622777, 622778, 622785, 622789, 622795, 622797, 622798, 622801, 622806, 623624, 623626, 623629, 623637, 623638, 623639, 623641, 623661, 623669, 623671, 623672, 623673, 623677, 623687, 623688, 623705, 623709, 623713, 623719, 623720, 623722, 623723, 623729, 623730, 623731, 623735, 623736, 623737, 623738, 623739, 623740, 623741, 623742, 623743, 623747, 623749, 623750, 623751, 623752, 623776, 623778, 623784, 623786, 623787, 623788, 623799, 623800, 623801, 623802, 624004, 624005, 624006, 624008, 624011, 624012, 624016, 624017, 624018, 624019, 624024, 624028, 624030, 624041, 624042, 624046, 624054, 624055, 624056, 624057, 624064, 624066, 624070, 624071, 624073, 624076, 624077, 624080, 624082, 624089, 624099, 624100, 624101, 624104, 624107, 624109, 624110, 624112, 624114, 624117, 624119, 624121, 624151, 624158, 624162, 624167, 624170, 624618, 624622, 624643, 624678, 624679, 624682, 624683, 624720, 622539, 622540, 622570, 622572, 623734, 623748, 624739, and 624741.

Obstetrical and Gynecological Devices

2

No

US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI.

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

TC003 (US Only) TC013 (US Only) TC033 (OUS Only) TC043 (OUS Only).   Code, Batch: TC04320, GMMG07; TC00320, GMMG08; TC00320, GMMG09; TC00320, GMMG10; TC04320, GMMG11; TC03320, GPMG01; TC04320, GPMG02; TC00320, GPMG03; TC00320, GPMG04; TC00320, GPMG05; TC01320, GPMG06; TC04320, GPMG07; TC03320, GPMG08; TC04320, GPMG09; TC00320, GPMG10; TC00320, GPMG11; TC00320, HAMG01; TC00320, HAMG02; TC03320, HAMG03; TC04320, HAMG04; TC00320, HAMG05; TC00320, HAMG06; TC00320, HAMG07; TC00320, HAMG08; TC01320, HAMG09; TC03320, HAMG10; TC04320, HAMG11; TC04320, HAMG12; TC00320, HAMG13; TC00320, HAMG14; TC00320, HBMG01; TC00320, HBMG02; TC04320, HBMG03; TC04320, HBMG04; TC03320, HBMG05; TC00320, HBMG06; TC00320, HBMG07; TC04320, HBMG08; TC03320, HBMG09; TC00320, HBMG10; TC00320, HCMG01; TC00320, HCMG02; TC00320, HCMG03; TC00320, HCMG04; TC04320, HCMG05; TC04320, HCMG06; TC03320, HDMG01; TC00320, HDMG02; TC00320, HDMG03; TC00320, HDMG04; TC00320, HDMG05; TC03320, HEMG01; TC04320, HEMG02; TC01320, HEMG03; TC00320, HEMG05; TC00320, HEMG06; TC00320, HEMG07; TC00320, HEMG08; TC04320, HEMG09; TC04320, HGMG01; TC03320, HGMG02; TC00320, HGMG03; TC00320, HGMG04; TC00320, HGMG05; TC00320, HGMG06; TC00320, HGMG07; TC04320, HGMG08; TC04320, HGMG09; TC04320, HGMG10; TC00320, HHMG01; TC00320, HHMG02; TC00320, HHMG03; TC00320, HHMG04; TC03320, HHMG05; TC04320, HHMG06; TC00320, HHMG08; TC00320, HHMG09; TC00320, HHMG10; TC04320, HHMG07; TC00320, HHMG11; TC00320, HHMG12; TC00320, HJMG02; TC00320, HJMG03; TC00320, HJMG04; TC00320, HJMG05; TC00320, HJMG06; TC01320, HJMG07; TC03320, HJMG08; TC04320, HJMG09; TC04320, HJMG10; TC00320, HJMG11; TC00320, HJMG12; TC00320, HJMG13; TC04320, HKMG01; TC00320, HJMG14; TC04320, HKMG02; TC03320, HKMG03; TC00320, HKMG04; TC00320, HKMG05; TC00320, HKMG06; TC04320, HKMG07; TC03320, HKMG08; TC00320, HKMG10; TC00320, HKMG09; TC00320, HKMG11; TC00320, HLMG01; TC00320, HLMG02; TC00320, HLMG03; TC01320, HLMG04; TC04320, HLMG05; TC03320, HLMG06; TC00320, HLMG07; TC00320, HLMG08; TC00320, HLMG09; TC04320, HLMG10; TC03320, HMMG01; TC04320, HMMG02; TC00320, HMMG03; TC00320, HMMG04; TC04320, HMMG05; TC00320, HMMG06; TC00320, HMMG07; TC00320, HPMG01; TC00320, HPMG02; TC04320, HPMG04; TC03320, HPMG03; TC04320, HPMG05; TC00320, HPMG06; TC00320, HPMG07; TC00320, JAMG01; TC00320, JAMG02; TC04320, JAMG03; TC00320, JAMG05; TC00320, JAMG04; TC01320, JAMG06; TC00320, JAMG07; TC04320, JAMG08; TC00320, JAMG10; TC03320, JAMG09; TC00320, JAMG11; TC00320, JBMG01; TC04320, JBMG02; TC04320, JBMG03; TC03320, JBMG04; TC00320, JBMG05; TC00320, JBMG06; TC00320, JBMG07; TC04320, JBMG08; TC00320, JBMG09; TC00320, JBMG10; TC00320, JBMG11; TC04320, JCMG01; TC03320, JCMG02; TC00320, JCMG03; TC00320, JCMG04; TC01320, JCMG05; TC04320, JDMG01; TC00320, JDMG02; TC00320, JDMG03; TC00320, JDMG04; TC04320, JDMG05; TC00320, JDMG06; TC04320, JDMG07; TC00320, JEMG01; TC00320, JEMG02; TC00320, JEMG03; TC00320, JEMG04; TC03320, JEMG05; TC00320, JGMG02; TC04320, JGMG03; TC03320, JGMG04; TC00320, JGMG05; TC00320, JGMG09; TC04320, JGMG10; TC04313, JGMG14; TC04320, JGMG15; TC00320, JGMG16; TC03320, JGMG17; TC00320, JGMG18; TC00320, JHMG02; TC04320, JHMG05; TC00320, JHMG03; TC04320, JHMG04; TC00320, JHMG06; TC00320, JHMG07; TC00320, JHMG08; TC00320, JHMG09; TC00320, JHMG10; TC04320, JHMG11; TC00320, JHMG12; TC03320, JJMG01; TC00320, JJMG02; TC00320, JJMG04; TC00320, JJMG05; TC01320, JJMG06; TC00320, JJMG07; TC03313, JJMG08; TC00320, JJMG09; TC04313, JKMG02; TC00320, JKMG01; TC03313, JKMG03; TC00320, JKMG04; TC00320, JKMG05; TC00320, JKMG06; TC00320, JKMG08; TC04313, JLMG01; TC00320, JLMG02; TC00320, JLMG04; TC03313, JLMG05; and TC00320, JLMG06. As of 1/8/2016, 5 Additional lots (US Only - JKMG01, JKMG04 and JKMG05; OUS Only - JKMG02 and JKMG03) were found to be affected by this field action.

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.

Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. || The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Lot# G154341 Exp: 4/14/18

Obstetrical and Gynecological Devices

1

No

Distributed US (nationwide) and in Canada.

PS-500 Scope Warmer; 10 units per box. || Pre-heating scope for laparoscopy surgery.

Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900012 OB SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15202 (150719828) 31-JUL-16 SL15203 (150719828) 31-JUL-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 9001294 || PREMIUM CESAREAN PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150619380) 30-JUN-16 SL15174 (150619380) 30-JUN-16 SL15201-01 (150719634) 31-JUL-16 SL15212 (150720070) 31-JUL-16 SL15212 (150720071) 31-JUL-16 SL15272 (150920769) 30-SEP-16 SL15273 (150920769) 30-SEP-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 9001297 || PREMIUM OBSTETRICAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15197 (150719792) 31-JUL-16 SL15208 (150719793) 31-JUL-16 SL15216 (150719793) 31-JUL-16 SL15225 (150820315) 31-AUG-16 SL15225 (150820314) 31-AUG-16 SL15230 (150820315) 31-AUG-16 SL15243 (150719793) 31-JUL-16 SL15272 (150920895) 30-SEP-16 SL15272 (150920819) 30-SEP-16 SL15272 (150920897) 30-SEP-16 SL15272 (150920896) 30-SEP-16 SL15273 (150920897) 30-SEP-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 9002940 || OBSTETRICAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15176 (150619271) 30-JUN-16 SL15177 (150619271) 30-JUN-16 SL15181 (150619271) 30-JUN-16 SL15201-01 (150719797) 31-JUL-16 SL15217 (150720129) 31-JUL-16 SL15217 (150720130) 31-JUL-16 SL15219 (150720131) 31-JUL-16 SL15219 (150720130) 31-JUL-16 SL15223 (150720129) 31-JUL-16 SL15224 (150720131) 31-JUL-16 SL15268 (150920822) 30-SEP-16 SL15271 (150920822) 30-SEP-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900403 || CESAREAN SECTION SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15177 (150619275) 30-JUN-16 SL15233 (150719849) 31-JUL-16 SL15240 (150719849) 31-JUL-16 SL15264 (150820590) 30-SEP-16 SL15264 (150920589) 30-SEP-16 SL15266 (150820590) 30-SEP-16 SL15274 (150920824) 31-AUG-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900410 || CESAREAN SECTION SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15180 (150619283) 30-JUN-16 SL15194 (150719803) 31-JUL-16 SL15243 (150820325) 31-AUG-16 SL15243 (150820324) 31-AUG-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900419 || LABOR & DELIVERY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15203 (150719885) 31-JUL-16 SL15271 (150920829) 30-SEP-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900484 || LAPAROSCOPIC GYNECOLOGY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15203 (150719886) 31-JUL-16 SL15243 (150820332) 31-AUG-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900486 || LAPAROSCOPY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15176 (150619404) 30-JUN-16 SL15199 (150719806) 31-JUL-16 SL15203 (150719806) 31-JUL-16 SL15211 (150720041) 31-JUL-16 SL15259 (150920577) 31-AUG-16 SL15260 (150920577) 31-AUG-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900548A || PERY-GYN SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15175 (150619191) 30-JUN-16 SL15177 (150619191) 30-JUN-16 SL15197 (150719813) 31-JUL-16 SL15199 (150719813) 31-JUL-16 SL15222 (150820354) 31-AUG-16 SL15222 (150820353) 31-AUG-16 SL15224 (150820353) 31-AUG-16 SL15225 (150820354) 31-AUG-16 SL15261 (150920717) 30-SEP-16 SL15261 (150920716) 30-SEP-16 SL15264 (150920716) 30-SEP-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900921A || C-SECTION SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15210 (150720046) 31-JUL-16 SL15210 (150719995) 31-JUL-16 SL15217 (150720047) 31-JUL-16 SL15244 (150720047) 31-JUL-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900997 || PERI-GYN SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15208 (150719996) 31-JUL-16 SL15222 (150820360) 31-AUG-16

Obstetrical and Gynecological Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900998 || CESAREAN SECTION SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.