Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
FDA Recall Z-2330-2018 · Posted None
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Recalling FirmSafe N Simple, LLC
Recall StatusTerminated
Product CodeNEC
Date Initiated2012-06-18
Date Terminated2020-05-28
Product Quantity17592
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.
Firm Action
On June 18, 2012, the firm disseminated "Important-Action Required" recall information to affected distributors via email or phone call. The notification requested all distributors to immediately stop selling the product. The following instructions were provided:
1. Quantity on hand should be emailed to safen'simple customer service manager, Michelle
Bliszack, [email protected]. We would like to know the current quantity you
have in inventory of the subject product by Tuesday, June 19th, 2012.
2. We request the product with lot number 20120115 be either discarded or returned back to
safen'simple. We will arrange and pay for shipment back to our warehouse. safen'simple will
replace all existing stock of lot number 20120115 at no charge with a new lot number.
3. Until we ship replacement product, appropriate substitutes in performance are products
SNS80725 and SNS80744. They are both similar product, however the size of the wipe is
smaller. Packaging is 25 wipes/box and 100 wipes/box respectively.
Root Cause
Process design
Distribution Pattern
Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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