Customed, Inc: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Agency Publication Date: April 14, 2016

Affected Products

Product: Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15215 (150719671) 31-JUL-16 SL15222 (150719671) 31-JUL-16 SL15246 (150820227) 31-AUG-16 SL15252 (150820227) 31-AUG-16

Product: Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16

Product: 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.

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

Product: Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15180 (150619409) 31-MAY-16 SL15181 (150619409) 31-MAY-16 SL15197 (150719607) 31-MAY-16 SL15201-01 (150719607) 31-MAY-16 SL15230 (150820136) 31-AUG-16 SL15251 (150820136) 31-AUG-16 SL15265 (150920652) 30-SEP-16 SL15266 (150920652) 30-SEP-16

Product: Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK

LOTS: SL15194 (150719926) 31-JUL-16 SL15194 (150719927) 31-JUL-16 SL15195-02 (150719927) 31-JUL-16 SL15195-02 (150719926) 31-JUL-16 SL15258 (150719926) 31-JUL-16 SL15258 (150719927) 31-JUL-16

Product: Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-16

Product: Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150418257) 30-APR-16 SL15170 (150418258) 30-APR-16 SL15181 (150619549) 30-JUN-16 SL15181 (150619548) 30-JUN-16 SL15199 (150719611) 31-JUL-16 SL15215 (150719612) 31-JUL-16 SL15216 (150719612) 31-JUL-16

Product: Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150619101) 30-JUN-16 SL15202 (150719613) 31-JUL-16 SL15245 (150820662) 31-AUG-16

Product: Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150317576) 28-FEB-16 SL15169 (150619102) 31-MAY-16 SL15169 (150518600) 31-MAY-16 SL15170 (150518600) 31-MAY-16 SL15173 (150619102) 31-MAY-16 SL15175 (150418229) 31-MAY-16 SL15199 (150719614) 31-MAY-16 SL15203 (150719614) 31-MAY-16 SL15225 (150719614) 31-MAY-16 SL15231 (150820140) 31-AUG-16 SL15243 (150820140) 31-AUG-16 SL15251 (150820140) 31-AUG-16 SL15272 (150920663) 30-SEP-16 SL15273 (150920663) 30-SEP-16

Product: Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150619313) 31-MAY-16 SL15174 (150619313) 31-MAY-16 SL15197 (150719820) 31-JUL-16 SL15202 (150719820) 31-JUL-16 SL15208 (150719820) 31-JUL-16 SL15274 (150920664) 30-SEP-16 SL15274 (150920144) 30-SEP-16 SL15275 (150920664) 30-SEP-16

Product: Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15187 (150619473) 30-JUN-16 SL15197 (150719616) 31-JUL-16 SL15240 (150820571) 31-AUG-16 SL15251 (150920666) 30-SEP-16 SL15259 (150920926) 30-SEP-16 SL15259 (150920925) 30-SEP-16

Product: Catalog Number: 9001061 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: SL15194 (150719821) 31-JUL-16 SL15243 (150820582) 31-AUG-16 SL15274 (150920674) 30-SEP-16

Product: Catalog Number: 9001062 ARTHROSCOPY 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 (150719822) 31-JUL-16 SL15203 (150719822) 31-JUL-16 SL15215 (150720063) 31-JUL-16 SL15216 (150720063) 31-JUL-16 SL15244 (150820583) 31-AUG-16 SL15246 (150820583) 31-AUG-16

Product: Catalog Number: 9001091 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: SL15202 (150719622) 31-JUL-16 SL15211 (150720064) 31-JUL-16 SL15212 (150720065) 31-JUL-16 SL15245 (150820677) 31-AUG-16 SL15245 (150820676) 31-AUG-16

Product: Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150619116) 30-JUN-16 SL15175 (150619116) 30-JUN-16 SV15168 (150518601) 30-JUN-16 SV15168 (150318049) 30-JUN-16 SL15199 (150719623) 31-JUL-16 SL15224 (150719623) 31-JUL-16 SL15225 (150820150) 31-AUG-16 SL15264 (150920928) 30-SEP-16 SL15264 (150920679) 30-SEP-16 SL15268 (150920928) 30-SEP-16

Product: Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15183 (150619119) 30-JUN-16 SL15184 (150619119) 30-JUN-16 SL15187 (150619119) 30-JUN-16 SL15212 (150719823) 31-JUL-16 SL15215 (150719823) 31-JUL-16 SL15216 (150719823) 31-JUL-16 SL15217 (150720152) 31-JUL-16 SL15217 (150719823) 31-JUL-16 SL15219 (150719823) 31-JUL-16 SL15219 (150720152) 31-JUL-16 SL15223 (150720152) 31-JUL-16 SL15224 (150720152) 31-JUL-16 SL15225 (150719823) 31-JUL-16 SL15252 (150820683 31-AUG-16 SL15254 (150820683) 31-AUG-16 SL15257 (150820683) 31-AUG-16

Product: Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15194 (150719924) 31-JUL-16 SL15210 (150719924) 31-JUL-16 SL15216 (150719925) 31-JUL-16 SL15218 (150719925) 31-JUL-16 SL15222 (150719824) 31-JUL-16 SL15224 (150719824) 31-JUL-16

Product: Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15195-01 (150719825) 31-JUL-16 SL15195-02 (150719825) 31-JUL-16 SL15197 (150719825) 31-JUL-16 SL15218 (150719825) 31-JUL-16 SL15232 (150820156) 31-AUG-16 SL15233 (150820156) 31-AUG-16

Product: Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SV15168 (150518595) 31-MAY-16 SL15223 (150719827) 31-JUL-16 SL15224 (150719827) 31-JUL-16 SL15225 (150719827) 31-JUL-16 SL15245 (150820633) 31-AUG-16 SL15246 (150820633) 31-AUG-16

Product: Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15208 (150719625) 31-JUL-16 SL15209 (150719625) 31-JUL-16 SL15217 (150720066) 31-JUL-16 SL15267 (150920686) 30-SEP-16 SL15271 (150920686) 30-SEP-16 SL15272 (150920686) 30-SEP-16

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

Product: Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16

Product: 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: 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

Product: Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15195-02 (150719829) 31-JUL-16

Product: Catalog Number: 9001300 NEURO-SPINE 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 (150619129) 30-JUN-16 SL15209 (150619381) 31-JUL-16 SL15215 (150619381) 31-JUL-16 SL15265 (150919830) 30-SEP-16 SL15265 (150920072) 30-SEP-16

Product: Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15175 (150619485) 30-JUN-16 SL15225 (150719857) 31-AUG-16 SL15230 (150820074) 31-AUG-16

Product: Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (140814647) 30-JUN-16 SL15202 (150719858) 31-JUL-16 SL15225 (150820446) 31-AUG-16

Product: Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15197 (150719929) 30-APR-16 SL15201-01 (150719929) 30-APR-16 SL15218 (150719929) 30-APR-16 SL15266 (150920778) 31-MAY-16

Product: Catalog Number: 9001460 REYITO PLUS UROLOGY 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 (150619550) 30-JUN-16 SL15202 (150619235) 30-JUN-16 SL15209 (150719642) 31-JUL-16 SL15209 (150619550) 30-JUN-16

Product: Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15201-01 (150719645) 31-JUL-16 SL15222 (150719959) 30-JUN-16 SL15223 (150719959) 30-JUN-16

Product: Catalog Number: 9001496 D&C 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: SL15181 (150619167) 30-JUN-16 SL15181 (150619386) 30-JUN-16 SL15209 (150619386) 30-JUN-16 SL15209 (150719646) 31-JUL-16 SL15224 (150820077) 31-AUG-16

Product: Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15173 (150619387) 30-JUN-16 SL15174 (150619387) 30-JUN-16 SL15194 (150719649) 31-JUL-16 SL15211 (150720078) 31-JUL-16 SL15211 (150720079) 31-JUL-16 SL15273 (150920693) 30-SEP-16 SL15275 (150920693) 30-SEP-16

Product: Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150619169) 31-MAY-16 SL15187 (150619170) 31-MAY-16 SL15201-01 (150719651) 31-MAY-16 SL15201-01 (150719650) 31-MAY-16 SL15233 (150820175) 31-AUG-16

Product: Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15194 (150719656) 31-JUL-16 SL15223 (150820181) 31-AUG-16 SL15223 (150820180) 31-AUG-16 SL15223 (150820182) 31-AUG-16

Product: Catalog Number: 900164 FEMORAL 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 (150619358) 30-JUN-16 SL15191-01 (150619359) 31-JUL-16 SL15211 (150719661) 31-JUL-16 SL15217 (150719661) 31-JUL-16 SL15245 (150720128) 31-AUG-16 SL15245 (150720127) 31-AUG-16

Product: Catalog Number: 900168 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: SL15244 (150820587) 30-JUN-16 SL15245 (150820587) 30-JUN-16 SL15251 (150719662) 30-JUN-16

Product: Catalog Number: 900169 UNIVERSAL 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 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16

Product: Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOT: SL15209 (150719960) 31-JUL-16

Lot Numbers:

SL15209

Product: Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150619367) 30-JUN-16 SL15170 (150619366) 30-JUN-16 SL15170 (150619364) 30-JUN-16 SL15170 (150619365) 30-JUN-16 SL15187 (150719668) 31-JUL-16 SL15191-01 (150719669) 31-JUL-16 SL15191-01 (150719670) 31-JUL-16 SL15191-01 (150719667) 31-JUL-16 SL15211 (150720120) 31-JUL-16 SL15211 (150720142) 31-JUL-16 SL15211 (150720122) 31-JUL-16 SL15212 (150720143) 31-JUL-16 SL15212 (150720142) 31-JUL-16 SL15212 (150720121) 31-JUL-16 SL15215 (150720122) 31-JUL-16 SL15215 (150720141) 31-JUL-16 SL15215 (150720121) 31-JUL-16 SL15222 (150720120) 31-JUL-16 SL15233 (150820566) 31-AUG-16 SL15233 (150820568) 31-AUG-16 SL15240 (150820569) 31-AUG-16 SL15243 (150820567) 31-AUG-16 SL15243 (150820566) 31-AUG-16 SL15245 (150820698) 31-AUG-16 SL15245 (150820697) 31-AUG-16 SL15245 (150820696) 31-AUG-16

Product: Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15199 (150719930) 31-JUL-16 SL15203 (150719930) 31-JUL-16 SL15232 (150820226) 31-AUG-16 SL15268 (150920789) 30-SEP-16 SL15243 (150820226) 31-AUG-16

LOTS: SL15215 (150719671) 31-JUL-16 SL15222 (150719671) 31-JUL-16 SL15246 (150820227) 31-AUG-16 SL15252 (150820227) 31-AUG-16

Product: Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150518594) 30-JUN-16 SL15170 (150518592) 30-JUN-16 SL15199 (150719720) 30-JUN-16 SL15199 (150719719) 30-JUN-16 SL15203 (150719720) 30-JUN-16 SL15230 (150819721) 30-JUN-16 SL15231 (150819722) 30-JUN-16 SL15231 (150820230) 30-JUN-16 SL15243 (150820231) 30-JUN-16 SL15243 (150820229) 30-JUN-16 SL15259 (150920791) 30-JUN-16 SL15259 (150920917) 30-JUN-16

Product: Catalog Number: 9001933 OPHTALMIC 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 (150619390) 30-JUN-16 SL15231 (150819833) 31-AUG-16 SL15233 (150619391) 31-AUG-16 SL15240 (150819834) 31-AUG-16 SL15259 (150920237) 30-SEP-16 SL15259 (150920236) 30-SEP-16

Product: Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15195-01 (150619229) 31-JUL-16 SL15210 (150619392) 31-JUL-16 SL15211 (150619392) 31-JUL-16 SL15223 (150719733) 31-AUG-16 SL15224 (150719733) 31-AUG-16 SL15275 (150920795) 30-SEP-16

Product: Catalog Number: 9002123 KNEE ARTHROSCOPY 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 (150619394) 30-JUN-16 SL15181 (150619394) 30-JUN-16 SL15203 (150719752) 31-JUL-16 SL15223 (150820261) 31-AUG-16

Product: Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150619249) 30-JUN-16 SL15174 (150619249) 30-JUN-16 SL15184 (150619395) 30-JUN-16 SL15210 (150719753) 31-JUL-16 SL15210 (150619395) 30-JUN-16 SL15273 (150920799) 30-SEP-16

Product: Catalog Number: 9002167 LITHOTOMY 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 (150619250) 30-JUN-16 SL15180 (150619397) 30-JUN-16 SL15180 (150619396) 30-JUN-16 SL15180 (150619250) 30-JUN-16 SL15202 (150719754) 31-JUL-16 SL15225 (150820263) 31-AUG-16 SL15225 (150820262) 31-AUG-16

Product: Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15229 (150719755) 31-AUG-16 SL15230 (150719755) 31-AUG-16 SL15231 (150719755) 31-AUG-16 SL15240 (150719755) 31-AUG-16 SL15260 (150820264) 30-SEP-16 SL15260 (150820265) 30-SEP-16 SL15261 (150820264) 30-SEP-16 SL15272 (150820264) 30-SEP-16

Product: Catalog Number: 9002224 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 (150519027) 30-JUN-16 SL15191-01 (150519026) 30-JUN-16 SL15211 (150719756) 31-JUL-16 SL15229 (150820266) 31-AUG-16 SL15258 (150920880) 30-SEP-16 SL15258 (150920802) 30-SEP-16

Product: Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15201-02 (150619399) 30-JUN-16 SL15203 (150619399) 30-JUN-16 SL15210 (150719862) 31-JUL-16 SL15260 (150820588) 30-SEP-16 SL15261 (150820588) 30-SEP-16

Product: Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15173 (150418356) 31-MAY-16 SL15195-01 (150619256) 30-JUN-16 SL15199 (150619256) 30-JUN-16 SL15208 (150719758) 31-JUL-16 SL15212 (150719758) 31-JUL-16 SL15224 (150719758) 31-JUL-16 SL15243 (150820288) 31-AUG-16 SL15260 (150920289) 30-SEP-16

Product: Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15181 (150619410) 30-JUN-16 SL15184 (150619410) 30-JUN-16 SL15223 (150820284) 31-AUG-16 SL15223 (150820283) 31-AUG-16

Product: Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15201-02 (150719840) 31-JUL-16 SL15259 (150920293) 30-SEP-16 SL15259 (150920294) 30-SEP-16

Product: Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150317841) 30-APR-16 SL15170 (150317843) 30-APR-16 SL15180 (150619260) 30-JUN-16 SL15184 (150317844) 30-APR-16 SL15199 (150719841) 31-JUL-16 SL15203 (150719841) 31-JUL-16 SL15229 (150820295) 31-AUG-16 SL15245 (150820296) 31-AUG-16 SL15246 (150820296) 31-AUG-16 SL15267 (150920885) 31-AUG-16 SL15268 (150920886) 31-AUG-16 SL15271 (150920887) 31-AUG-16 SL15273 (150920884) 31-AUG-16 SL15273 (150920809) 31-AUG-16

Product: Catalog Number: 9002516 LAPAROTOMY 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 (150719261) 31-JUL-16 SL15203 (150719842) 31-JUL-16 SL15211 (150719261) 31-JUL-16 SL15211 (150719842) 31-JUL-16 SL15244 (150820297) 31-AUG-16 SL15245 (150820297) 31-AUG-16

Product: Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15202 (150719846) 31-JUL-16 SL15203 (150719846) 31-JUL-16 SL15229 (150820299) 31-AUG-16 SL15231 (150820299) 31-AUG-16

Product: Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15212 (150719962) 31-JUL-16 SL15274 (150920990) 30-JUN-16 SL15274 (150920989) 30-SEP-16

Product: Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15181 (150619402) 30-JUN-16 SL15184 (150619402) 30-JUN-16 SL15184 (150619265) 30-JUN-16 SL15274 (150820300) 30-SEP-16 SL15275 (150820301) 30-SEP-16 SL15275 (150820300) 30-SEP-16

Product: Catalog Number: 9002618 OPEN HEART 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 (150619477) 30-JUN-16 SL15181 (150619477) 30-JUN-16 SL15212 (150719843) 31-JUL-16 SL15215 (150719843) 31-JUL-16 SL15219 (150719843) 31-JUL-16 SL15271 (150920812) 30-SEP-16

Product: Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15201-02 (150619403) 31-JUL-16 SL15201-02 (150619266) 31-JUL-16 SL15202 (150619403) 31-JUL-16 SL15208 (150619403) 31-JUL-16 SL15232 (150820302) 31-AUG-16 SL15243 (150820302) 31-AUG-16 SL15246 (150820303) 31-AUG-16 SL15251 (150820303) 31-AUG-16

Product: Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15184 (150518788) 30-JUN-16 SL15210 (150719844) 31-JUL-16 SL15212 (150719844) 31-JUL-16 SL15243 (150820304) 31-AUG-16 SL15244 (150820304) 31-AUG-16

Product: Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15175 (150518789) 30-APR-16 SL15177 (150518789) 30-APR-16 SL15180 (150619314) 30-APR-16 SL15183 (150619314) 30-APR-16 SL15232 (150820305) 31-MAY-16 SL15233 (150820305) 31-MAY-16 SL15233 (150719845) 31-MAY-16 SL15243 (150719845) 31-MAY-16 SL15268 (150920814) 31-MAY-16

Product: Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SV15168 (150217396) 28-FEB-16 SL15201-02 (150719848) 31-JUL-16 SL15208 (150719848) 31-JUL-16 SL15229 (150820306) 31-AUG-16 SL15231 (150820306) 31-AUG-16 SL15265 (150920815) 31-AUG-16 SL15266 (150920815) 31-AUG-16 SL15267 (150920815) 31-AUG-16

Product: Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15194 (150719776) 31-JUL-16 SL15197 (150719778) 31-JUL-16 SL15199 (150719777) 31-JUL-16 SL15201-01 (150719777) 31-JUL-16 SL15217 (150720038) 31-AUG-16 SL15219 (150720039) 31-AUG-16 SL15222 (150720039) 31-AUG-16 SL15222 (150720038) 31-AUG-16 SL15225 (150720040) 31-AUG-16 SL15231 (150720040) 31-AUG-16 SL15271 (150920908) 30-SEP-16 SL15271 (150920640) 30-SEP-16

Product: Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15187 (150719782) 31-JUL-16 SL15191-01 (150719783) 31-JUL-16 SL15244 (150820308) 31-AUG-16 SL15264 (150820309) 30-SEP-16 SL15273 (150820307) 30-SEP-16 SL15274 (150820307) 30-SEP-16

Product: Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15187 (150619316) 30-JUN-16 SL15195-01 (150719785) 31-JUL-16 SL15265 (150820310) 30-SEP-16 SL15271 (150820311) 30-SEP-16

Product: Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15174 (150518912) 30-JUN-16 SL15240 (150820312) 31-AUG-16

Product: 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: 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

Product: Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15195-02 (150619269) 31-JUL-16 SL15251 (150820570) 31-AUG-16

Product: Catalog Number: 900345 BASIC 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 (150719872) 31-JUL-16 SL15225 (150820317) 31-AUG-16 SL15274 (150920821) 30-SEP-16

Product: 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: 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

Product: 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: 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

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

Product: Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150418502) 30-APR-16 SL15173 (150619371) 30-JUN-16 SL15180 (150619553) 30-JUN-16 SL15180 (150619552) 30-JUN-16 SL15184 (150619553) 30-JUN-16 SL15195-01 (150719884) 31-JUL-16 SL15195-02 (150719884) 31-JUL-16 SL15197 (150719884) 31-JUL-16 SL15265 (150920827) 30-SEP-16 SL15273 (150920592) 30-SEP-16 SL15274 (150920592) 30-SEP-16

Product: Catalog Number: 900474 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: SL15169 (150619284) 30-APR-16 SL15173 (150619372) 30-JUN-16 SL15195-02 (150619554) 30-JUN-16 SL15195-02 (150719804) 30-APR-16 SL15264 (150820330) 31-AUG-16 SL15274 (150920828) 31-AUG-16 SL15275 (150920828) 31-AUG-16

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

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

Product: Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SV15168 (150418240) 30-APR-16 SL15209 (150719850) 31-JUL-16 SL15218 (150719850) 31-JUL-16 SL15229 (150719850) 31-JUL-16 SL15244 (150820336) 31-AUG-16 SL15251 (150719850) 31-JUL-16 SL15252 (150719850) 31-JUL-16 SL15254 (150719850) 31-JUL-16 SL15254 (150820336) 31-AUG-16 SL15257 (150820336) 31-AUG-16 SL15258 (150820336) 31-AUG-16

Product: Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15174 (150518822) 31-MAY-16 SL15176 (150317997) 31-MAR-16 SV15168 (150418241) 30-APR-16 SV15168 (150117022) 31-MAR-16 SL15180 (150418241) 30-APR-16 SL15209 (150720052) 31-JUL-16 SL15210 (150720052) 31-JUL-16 SL15218 (150720052) 31-JUL-16 SL15219 (150720052) 31-JUL-16 SL15222 (150720052) 31-JUL-16 SL15246 (150820337) 31-AUG-16 SL15251 (150820337) 31-AUG-16 SL15252 (150820337) 31-AUG-16

Product: Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15195-01 (150719852) 31-JUL-16 SL15195-02 (150719852) 31-JUL-16 SL15218 (150719852) 31-JUL-16

Product: Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15187 (150719805) 31-JUL-16 SL15245 (150820338) 31-AUG-16 SL15264 (150920833) 30-SEP-16

Product: 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: 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

Product: Catalog Number: 900576A LAP-CHOLECYSTECTOMY 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 (150719807) 31-JUL-16 SL15240 (150820565) 31-AUG-16 SL15240 (150820339) 31-AUG-16 SL15261 (150920708) 30-SEP-16 SL15261 (150920707) 30-SEP-16 SL15264 (150920707) 30-SEP-16

Product: Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15187 (150518831) 30-JUN-16 SL15217 (150719853) 31-JUL-16 SL15233 (150820340) 31-AUG-16

Product: Catalog Number: 900618A LAPAROSCOPY-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: SL15197 (150719808) 31-JUL-16 SL15240 (150820341) 31-AUG-16 SL15271 (150920991) 30-SEP-16

Product: Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150619291) 30-JUN-16 SL15191-01 (150719893) 31-JUL-16 SL15223 (150820342) 31-AUG-16 SL15225 (150820343) 31-AUG-16

Product: Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15203 (150719894) 31-JUL-16 SL15208 (150518835) 31-MAY-16

Product: Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15169 (150619188) 30-JUN-16 SL15174 (150619405) 30-JUN-16 SL15202 (150719809) 31-JUL-16 SL15208 (150719809) 31-JUL-16 SL15210 (150720043) 31-JUL-16 SL15222 (150720043) 31-JUL-16 SL15233 (150720042) 31-JUL-16 SL15251 (150720042) 31-JUL-16 SL15260 (150920709) 30-SEP-16

Product: Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15174 (150619406) 30-JUN-16 SL15197 (150719810) 31-JUL-16 SL15201-02 (150719810) 31-JUL-16 SL15231 (150820049) 31-AUG-16 SL15232 (150820049) 31-AUG-16 SL15243 (150820049) 31-AUG-16 SL15265 (150820558) 31-AUG-16 SL15268 (150920711) 30-SEP-16

Product: Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15174 (150619190) 30-JUN-16 SL15181 (150619407) 30-JUN-16 SL15191-01 (150619407) 30-JUN-16 SL15197 (150719811) 31-JUL-16 SL15201-01 (150719811) 31-JUL-16 SL15254 (150820367) 30-SEP-16 SL15265 (150920712) 30-SEP-16

Product: Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15177 (150619315) 30-JUN-16 SL15268 (150719854) 30-SEP-16 SL15271 (150719854) 30-SEP-16

Product: Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15191-01 (150719819) 31-JUL-16 SL15264 (150719819) 31-JUL-16

Product: Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15173 (150418424) 30-JUN-16 SL15175 (150619376) 30-JUN-16 SL15176 (150619376) 30-JUN-16 SL15202 (150619296) 31-JUL-16 SL15202 (150619470) 31-JUL-16 SL15203 (150719296) 31-JUL-16 SL15208 (150719812) 31-JUL-16 SL15211 (150719812) 31-JUL-16 SL15216 (150719812) 31-JUL-16 SL15266 (150920349) 30-SEP-16 SL15267 (150920350) 30-SEP-16

Product: 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: 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

Product: Catalog Number: 900944 CATARACT 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 (150619377) 30-JUN-16 SL15184 (150619377) 30-JUN-16 SL15229 (150619378) 31-AUG-16 SL15230 (150819814) 31-AUG-16 SL15231 (150820356) 31-AUG-16 SL15231 (150819816) 31-AUG-16 SL15231 (150819815) 31-AUG-16 SL15259 (150920355) 30-SEP-16 SL15261 (150920357) 30-SEP-16 SL15266 (150920358) 30-SEP-16

Product: Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOT: SL15215 (150719817) 31-JUL-16

Lot Numbers:

SL15215

Product: Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15170 (150518850) 30-JUN-16 SL15210 (150720045) 31-JUL-16 SL15210 (150720044) 31-JUL-16

Product: Catalog Number: 900996 LAPAROTOMY 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 (150619484) 30-JUN-16 SL15181 (150619555) 30-JUN-16 SL15222 (150820359) 31-AUG-16 SL15271 (150920720) 30-SEP-16

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

Product: 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.

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72992

Status: Resolved

Manufacturer: Customed, Inc

Manufactured In: United States

Units Affected: 100 products (540; 9000; 32; 4400; 60; 900; 132; 40; 4550; 600; 140; 30; 16; 80; 2800; 2920; 380; 2088; 1020; 42; 45; 258; 220; 85; 81; 15; 40; 200; 35; 70; 12; 24; 550; 270; 55; 15; 9; 25; 938; 3700; 540; 168; 168; 20; 12; 24; 150; 42; 280; 24; 84; 30; 90; 344; 76; 18; 18; 136; 47; 24; 39; 5650; 2450; 597; 152; 85; 72; 304; 96; 55; 48; 96; 44; 110; 120; 30; 60; 5712; 1148; 620; 10; 150; 144; 800; 36; 125; 1920; 108; 153; 162; 800; 580; 16; 238; 576; 8; 25; 111; 30; 32)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products