Recall Z-1417-2009 ยท GDM Needle, Aspiration And Injection, Reusable
Remington Medical Inc.
CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.
| Date | May 26, 2009 (initiated Apr 6, 2009) |
| Status | Terminated |
| Reason | Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked. |
| Root cause | Other |
| Action | The distributor was notified on Monday, April 6, 2009 via telephone by the QA Manager and a return authorization was issued. A notification letter dated April 13, 2009 was issued via certified mail to the affected customers. The letter described the affected product, reason for recall and actions for customers. Customers were also instructed to conduct recall to user level. For questions or additional information, contact Remington Medical, Inc. by calling 800-989-0057, extension 123. |
| Quantity | 60 units |
| Distribution | Nationwide Distribution -- KY and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.