Recall Z-2330-2018— Safe N Simple, LLC
Class II · Terminated
Class II FDA medical device recall by Safe N Simple, LLC, initiated 2012-06-18, terminated 2020-05-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807. 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..
- Recalling firm
- Safe N Simple, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-18
- Terminated
- 2020-05-28
- Firm location
- Clarkston, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.