Recall Z-1412-2016

Customed, Inc · initiated January 7, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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

Reason for recall

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

FDA-determined cause: Packaging

Action taken

Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.

Details

Recall number
Z-1412-2016
Initiated
January 7, 2016
Posted by FDA
April 14, 2016
Terminated
May 3, 2017
Quantity
2920
Distribution
Distributed only in Puerto Rico.
Recalling firm
Customed, Inc, Fajardo

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1397-2016 Class IICatalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1398-2016 Class IICatalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1399-2016 Class IICatalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1400-2016 Class IICatalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1401-2016 Class IICatalog Number: 900028 LAPAROSCOPY SURGICAL PACKRecall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1402-2016 Class IICatalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1403-2016 Class IICatalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1404-2016 Class IICatalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1405-2016 Class IICatalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1406-2016 Class IICatalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1407-2016 Class IICatalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1408-2016 Class IICatalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1409-2016 Class IICatalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1410-2016 Class IICatalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1411-2016 Class IICatalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1413-2016 Class IICatalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1414-2016 Class IICatalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1415-2016 Class IICatalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1416-2016 Class IICatalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1417-2016 Class IICatalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1418-2016 Class IICatalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1419-2016 Class IICatalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1420-2016 Class IICatalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1421-2016 Class IICatalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1422-2016 Class IICatalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1423-2016 Class IICatalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1424-2016 Class IICatalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1425-2016 Class IICatalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1426-2016 Class IICatalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated
Z-1427-2016 Class IICatalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 01/07/2016Terminated