Device product
ANGIODRAPE 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-2548-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 packs
- Official record key
device-enforcement:Z-2548-2015
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: 900002 Lots: 140714427 exp. 7/30/2017 141014965 exp. 7/30/2017 150116709 exp. 1/31/2016 150318103 exp. 3/31/2016 150418510 exp. 4/30/2016 150519016 exp. 5/31/2016
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