Recall Z-0697-05 ยท KNW Instrument, Biopsy
Remington Medical Inc.
Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
| Date | Apr 8, 2005 (initiated Feb 15, 2005) |
| Status | Terminated |
| Reason | The stylet hub detaches from the stylet needle. |
| Root cause | Other |
| Action | Consignees were notified by letter on 02/15/2005. |
| Quantity | 1737 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982401 | PROSTATE BIOPSY NEEDLE Remington Medical, Inc., Sep 8, 1998 |