Device product
ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2622-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1128
- Official record key
device-enforcement:Z-2622-2015
Official wording
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information: Code:900210 Lots: 140915501 exp. 10/31/15 140915501 exp. 10/31/15 150116702 exp. 2/28/16 150116701 exp. 1/31/16 150116703 exp. 1/31/16 150116704 exp. 1/31/16 150116705 exp. 1/31/16 150116706 exp. 1/31/16 150217378 exp. 2/28/16 150217379 exp. 2/28/16 150217380 exp. 2/28/16 150217381 exp. 2/28/16 150217382 exp. 2/28/16 150317721 exp. 3/31/16 150317720 exp. 3/31/16 150318115 exp. 3/31/16 150318116 exp. 3/31/16 150318117 exp. 3/31/16 150318118 exp. 3/31/16 150418270 exp. 4/30/16 150418271 exp. 4/30/16 150418272 exp. 4/30/16 150418273 exp. 4/30/16
Distribution pattern: Distributed Only in Puerto Rico.
Derived failure modes
-
Manufacturing or process control
inadequate validation/qualification of sterilization processes
-
Sterility assurance
inadequate validation/qualification of sterilization