Device product
SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-2549-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20200 kits
- Official record key
device-enforcement:Z-2549-2015
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: 900010 Lots: 141015851 exp. 10/31/2015 150116710 exp.1/31/2016 150117001 exp.2/28/2016 150317560 exp.3/31/2016 150317560 exp.3/31/2016 150418252 exp.5/31/2016 150418252 exp.5/31/2016 150518605 exp.5/31/2016 150518605 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