Safe N Simple Ostomy Skin Barrier Wipes Recalled for Bacterial Contamination
Safe N Simple is recalling No-Sting Skin Barrier Film wipes due to confirmed bacterial contamination that poses a risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with confirmed bacterial contamination posing a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Safe N Simple, LLC is recalling 17,592 units of Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, model SNS00807. The recall was initiated after the manufacturer received a customer complaint regarding observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination.
The affected product was distributed to distributors in California, Florida, Ohio, Michigan, New Jersey, New York, Pennsylvania, Texas, and Virginia. The product code is 20120115.
The bacterial contamination presents a potential risk of infection to users. Consumers should stop using the product and contact Safe N Simple, LLC for further instructions.
The recalled product
- Product
- Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
- Manufacturer
- Safe N Simple, LLC
- Category
- Medical Device — Ostomy Care
- Affected units
- 17,592
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 20120115.
Distribution
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