FDA-Device2018-07-04Class II

Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

Safe N Simple, LLC
Hazard

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.

Sold states
Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Affected count
17592
Manufactured in
5827 Terex, Clarkston, MI, United States
Products
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2018

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