Class 2 Device Recall NARMD MEDICAL DEPOT

• Date Initiated by Firm: July 25, 2022
• Create Date: August 18, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1554-2022
• Recall Event ID: 90668
• Product Classification: Forceps - Product Code HTD
• Product: NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
• Code Information: SKU/Part Number: ZZ-0701; Lots: 22027483172 and 22131487071 UDI/DI: M752ZZ07010
• FEI Number: 1000111025
• 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: 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: 850 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.