Recall Z-2330-2018 ยท NEC Bandage, Liquid, Skin Protectant
Safe N Simple, LLC
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
| Date | Jun 18, 2012 |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| 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, mbliszack@snsmedicalwipes.com. 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 |
| Quantity | 17592 |
| Distribution | Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.