Class 2 Device Recall Bone Marrow Aspiration Needle

• Date Initiated by Firm: June 18, 2015
• Date Posted: July 21, 2015
• Recall Status: Terminated on June 23, 2016
• Recall Number: Z-2188-2015
• Recall Event ID: 71533
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
• Code Information: Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: Rebecca Ellis; 972-403-0749
• Manufacturer Reason for Recall: Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
• FDA Determined Cause: Packaging process control
• Action: The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.
• Quantity in Commerce: 6390 units
• Distribution: US
• 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.