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
This recall has been terminated (originally issued July 21, 2015).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- June 18, 2015
- Posted
- July 21, 2015
- Terminated
- June 23, 2016
- Recall Number
- Z-2188-2015
- Quantity
- 6390 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
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.
Distribution
US
Lot / Code Info
Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707
Root Cause
Packaging process control
Action Taken
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.
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