| Class 2 Device Recall Safe N Simple NoSting Skin Barrier Film | |
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 |
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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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