Recall Z-1469-2016

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: 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.

Codes / lots: LOTS: SL15180 (150619283) 30-JUN-16 SL15194 (150719803) 31-JUL-16 SL15243 (150820325) 31-AUG-16 SL15243 (150820324) 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-1469-2016
Initiated
January 7, 2016
Posted by FDA
April 14, 2016
Terminated
May 3, 2017
Product code
OKV – Obstetrical Kit
Quantity
44
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-1412-2016 Class IICatalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used…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