Home / Recalls / Customed, Inc / Z-1483-2016

Z-1483-2016 Class II Terminated

Recalled by Customed, Inc — Fajardo, PR

Recall Details

Product Type
Devices
Report Date
April 20, 2016
Initiation Date
January 7, 2016
Termination Date
May 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1920

Product Description

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.

Reason for Recall

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

Distribution Pattern

Distributed only in Puerto Rico.

Code Information

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

Other recalls by Customed, Inc

  • Z-1475-2016 Class II — Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI (January 7, 2016)
  • Z-1443-2016 Class II — Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to per (January 7, 2016)
  • Z-1478-2016 Class II — Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perfo (January 7, 2016)
  • Z-1449-2016 Class II — Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perfo (January 7, 2016)
  • Z-1488-2016 Class II — Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to p (January 7, 2016)
  • Z-1405-2016 Class II — Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform s (January 7, 2016)
  • Z-1440-2016 Class II — Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to pe (January 7, 2016)
  • Z-1415-2016 Class II — Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surg (January 7, 2016)
  • Z-1461-2016 Class II — Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform sur (January 7, 2016)
  • Z-1397-2016 Class II — Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perf (January 7, 2016)