Recall Z-2578-2015

Customed, Inc · initiated July 10, 2015

Class II Terminated

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

Product

PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Codes / lots: Code:9001298 Lots: 141015770 exp. 11/30/15 141115977 exp. 11/30/15 150116759 exp. 2/28/16

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

Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Details

Recall number
Z-2578-2015
Initiated
July 10, 2015
Posted by FDA
September 3, 2015
Terminated
April 12, 2017
Product code
HRX – Arthroscope
Quantity
55 packs
Distribution
Distributed Only in Puerto Rico.
Recalling firm
Customed, Inc, Fajardo

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2548-2015 Class IIANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2549-2015 Class IISUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2550-2015 Class IIO.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2551-2015 Class IIIRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2552-2015 Class IILAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2553-2015 Class IIUNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2554-2015 Class IIMAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2555-2015 Class IIMINOR PROCEDURE PACK 40/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2556-2015 Class IIWOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2557-2015 Class IIWOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2558-2015 Class IICYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2559-2015 Class IIOB PACK CS/4 Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2560-2015 Class IIARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2561-2015 Class IILAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2562-2015 Class IIPERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2563-2015 Class IIARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2564-2015 Class IIPERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2565-2015 Class IITRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2566-2015 Class IIFOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2567-2015 Class IIFOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2568-2015 Class IINEURO PACK 3/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2569-2015 Class IIWOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2570-2015 Class IILAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2571-2015 Class IILAPAROSC. OB GYN PK 5/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2572-2015 Class IIOPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2573-2015 Class IIWOUND MANAGEMENT TRAY II 30/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2574-2015 Class IILAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2575-2015 Class IIPREMIUM CESAREAN PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2576-2015 Class IIPREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated
Z-2577-2015 Class IIPREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… 07/10/2015Terminated