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U.S. Department of Health and Human Services

Class 2 Device Recall NARMD MEDICAL DEPOT

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  Class 2 Device Recall NARMD MEDICAL DEPOT see related information
Date Initiated by Firm July 25, 2022
Create Date August 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-1552-2022
Recall Event ID 90668
Product Classification Scissors, general, surgical - Product Code LRW
Product NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Code Information SKU/Part Number: ZZ-0697; Lots: 22026482044 and 22152487922 UDI/DI: M752ZZ06970
Recalling Firm/
Manufacturer		 Stradis Medical, LLC dba Stradis Healthcare
3025 Northwoods Pkwy
Peachtree Corners GA 30071-1524
For Additional Information Contact
800-886-7257
Manufacturer Reason
for Recall		 The sterile barrier may be compromised.
FDA Determined
Cause 2		 Under Investigation by firm
Action Stradis notified its sole consignee on 07/25/2022 by email. The notice explained the reason for the recall and the hazard, and requested the consignee contact customer service to arrange for the return and credit of the affected product. Should the product be further distributed, the consignee was directed to notify its customers within 48 hours of receipt of the notice. Those customers were directed to contact Stradis directly to arrange return and credit.
Quantity in Commerce 50 units
Distribution US Nationwide distribution in the state of SC.
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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