Recall Z-2188-2015 ยท KNW Instrument, Biopsy
Argon Medical Devices, Inc
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
| Date | Jul 21, 2015 (initiated Jun 18, 2015) |
| Status | Terminated |
| Reason | Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. |
| Root 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 | 6390 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.