Device product
PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2562-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 228 packs
- Official record key
device-enforcement:Z-2562-2015
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:9001061 Lots: 141015757 exp. 10/31/15 141216313 exp. 12/31/15 150116727 exp. 1/31/16 150116973 exp. 1/31/16 150116980 exp. 1/31/16 150418280 exp. 4/30/16 150518620 exp. 5/31/16 150519110 exp. 5/31/16
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