Device product
MAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2554-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1084 packs
- Official record key
device-enforcement:Z-2554-2015
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:900036 Lots: 141015515 exp. 11/30/15 141015515 exp. 11/30/15 141216311 exp. 12/31/15 150116932 exp. 1/31/16 150116931 exp. 1/31/16 150116935 exp. 1/31/16 150116934 exp. 1/31/16 150116933 exp. 1/31/16 150217245 exp. 1/31/16 150217246 exp. 1/31/16 150217247 exp. 1/31/16 150317571 exp. 3/31/16 150317572 exp. 3/31/16 150317573 exp. 3/31/16 150317575 exp. 4/30/16 150317574 exp. 4/30/16 150418256 exp. 4/30/16 150418256 exp. 4/30/16 150418257 exp. 4/30/16 150418258 exp. 4/30/16 150418259 exp. 4/30/16 150518615 exp. 5/31/16 150518616 exp. 5/31/16 150518616 exp. 5/31/16 150519020 exp. 5/31/16 150519019 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