Z-2330-2018 Class II Terminated

Recalled by Safe N Simple, LLC — Clarkston, MI

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.