FDAClass IIJuly 4, 2018

Safe N Simple No-Sting Skin Barrier Film recall: Contamination

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

Why was Safe N Simple No-Sting Skin Barrier Film 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

20120115.

Product
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Recalling firm
Safe N Simple, LLC
Quantity
17592
Distribution
Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Recall date
July 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls