Device product
EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2634-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148
- Official record key
device-enforcement:Z-2634-2015
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:9002438 Lots: 140915317 exp. 2/29/16 140714246 exp. 11/30/15 141216303 exp. 12/31/15 150116527 exp. 1/31/16 150317827 exp. 5/31/16 150418359 exp. 5/31/16 150518812 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