Z-2330-2018 Class II Terminated
FDA device recall Z-2330-2018 was initiated by Safe N Simple, LLC on June 18, 2012 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 28, 2020). Affected quantity: 17592.
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2018
- Initiation Date
- June 18, 2012
- Termination Date
- May 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17592
Product Description
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Reason for Recall
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.
Distribution Pattern
Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Code Information
20120115.