Recall Z-2674-2015
Customed, Inc · initiated July 10, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CESAREAN PACK 2/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:900410 Lots: 141015763 exp. 10/31/15 140814986 exp. 10/31/15 141216332 exp. 12/31/15 141216332 exp. 12/31/15 150116562 exp. 1/31/16 150317651 exp. 3/31/16 150317975 exp. 3/31/16 150317978 exp. 3/31/16 150317976 exp. 4/30/16 150317977 exp. 4/30/15 150518814 exp. 5/31/16
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-2674-2015
- Initiated
- July 10, 2015
- Posted by FDA
- September 3, 2015
- Terminated
- April 12, 2017
- Product code
- OHM – Cesarean Section Tray
- Quantity
- 490
- Distribution
- Distributed Only in Puerto Rico.
- Recalling firm
- Customed, Inc, Fajardo
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2548-2015 Class II | ANGIODRAPE 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 II | SUTURE 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 II | O.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 II | IRRIGATION 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 II | LAPAROSCOPY 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 II | UNIVERSAL 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 II | MAJOR 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 II | MINOR 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 II | WOUND 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 II | WOUND 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 II | CYSTO 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 II | OB 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 II | ARTHROSCOPY 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 II | LAPAROSC 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 II | PERI 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 II | ARTHROSCOPY 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 II | PERY 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 II | TRACHEOTOMY 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 II | FOLEY 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 II | FOLEY 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 II | NEURO 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 II | WOUND 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 II | LAPAROSCOPY 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 II | LAPAROSC. 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 II | OPEN 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 II | WOUND 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 II | LAMINECTOMY 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 II | PREMIUM 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 II | PREMIUM 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 II | PREMIUM 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 |