Recall Z-0673-2007 ยท KNW Instrument, Biopsy
Remington Medical Inc.
Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
| Date | Mar 29, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| Reason | Pouches were not sealed prior to sterilization. |
| Root cause | Other |
| Action | Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory. |
| Quantity | 192 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 |