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U.S. Department of Health and Human Services

Class 2 Device Recall Safe N Simple NoSting Skin Barrier Film

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  Class 2 Device Recall Safe N Simple NoSting Skin Barrier Film see related information
Date Initiated by Firm June 18, 2012
Create Date June 29, 2018
Recall Status1 Terminated 3 on May 28, 2020
Recall Number Z-2330-2018
Recall Event ID 80232
Product Classification Bandage, liquid, skin protectant - Product Code NEC
Product Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Code Information 20120115.
Recalling Firm/
Manufacturer		 Safe N Simple, LLC
5827 Terex
Clarkston MI 48346-1717
For Additional Information Contact Mr. Anthony T. Sajan
248-875-0840
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 17592
Distribution Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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