Device product
LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2552-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 339 packs
- Official record key
device-enforcement:Z-2552-2015
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: Catalog number:900028 Lots: 141015610 exp. 10/31/15 140814877 exp. 10/31/15 140814877 exp. 10/31/15 140814877 exp. 10/31/15 150116717 exp. 1/31/16 150116716 exp. 10/31/15 150116715 exp. 10/31/15 150116719 exp. 1/31/16 150116714 exp. 10/31/15 150116718 exp. 1/31/16
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