Device product
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Z-2330-2018
Product summary
- Event
- Event 80232
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17592
- Official record key
device-enforcement:Z-2330-2018
Official wording
Reason: The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.
Code information: 20120115.
Distribution pattern: Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Derived failure modes
-
Microbial contamination
bacterial contamination