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U.S. Department of Health and Human Services

Class 2 Device Recall Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER

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  Class 2 Device Recall Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER see related information
Date Initiated by Firm August 22, 2018
Create Date November 07, 2018
Recall Status1 Open3, Classified
Recall Number Z-0401-2019
Recall Event ID 81150
Product Classification Dressing, wound, hydrogel without drug and/or biologic - Product Code NAE
Product Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Code Information lot number 18060564
Recalling Firm/
Manufacturer
Safe N Simple, LLC
5827 Terex
Clarkston MI 48346-1717
For Additional Information Contact Anthony Sajan
248-875-0840
Manufacturer Reason
for Recall
The sterilization process used was unqualified.
FDA Determined
Cause 2
Process control
Action Safe n Simple extended the recall to the only customer that ordered the product in the lot numbers (see table). The firm provided a written notice to the customer mentioned in the table with specific instructions along with a phone conversation. Safe n Simple instructed the customer to provide the inventory level of SNS58315 and SNS58345 specific to lot numbers 18060564 and 18060563 respectively and to return such product to Safe N Simple LLC at Safe N Simple LLC expense. The effectiveness of the recall was good since the customer immediately responded by shipping all their inventory back to us.
Quantity in Commerce 125 cases
Distribution CA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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