Date Initiated by Firm |
August 22, 2018 |
Create Date |
November 07, 2018 |
Recall Status1 |
Terminated 3 on March 17, 2020 |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|