Recall Z-0771-2023 ยท KNW Instrument, Biopsy
Remington Medical, Inc.
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
| Date | Dec 28, 2022 (initiated Dec 2, 2022) |
| Status | Terminated |
| Reason | The stylet is longer than specified on the label |
| Root cause | Under Investigation by firm |
| Action | The firm issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 12/02/2022 by email. The notice requested the following: "Actions to be Taken: The following steps are to be taken by all impacted customers: 1. Please be aware that this issue may be present in your company s inventory (refer to the impacted lot number listed below). Please communicate the possibility of this issue to all parties in your facility who may be impacted so that they are aware of the potential risks associated with this product and so replacement products may be obtained, if necessary. 2. Complete the en |
| Quantity | 290 devices |
| Distribution | NC, WV, CA, PA, AL, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) Remington Medical, Inc., Jul 12, 2019 |