Medical device recalls Moderate risk

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

Recall date
June 18, 2012
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2330-2018
FDA classification
Class II
Brand / firm
Safe N Simple, LLC
Sold / distributed
Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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