Recall Z-2189-2015 ยท KNW Instrument, Biopsy
Argon Medical Devices, Inc
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
| 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 | 10290 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW Medical Device Technologies, Inc., Feb 3, 1998 |