Recall Z-1194-2017 ยท KNW Instrument, Biopsy
Argon Medical Devices, Inc
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
| Date | Feb 13, 2017 (initiated Jan 18, 2017) |
| Status | Terminated |
| Reason | The recalling firm received a complaint from one of their customers of a 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 | Equipment maintenance |
| Action | Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749. |
| Quantity | 497 boxes |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan. |
| 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 |