Remington Medical Inc.
Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
| Date | Sep 20, 2009 (initiated Jun 19, 2009) |
| Status | Terminated |
| Reason | Two unsealed pouches were identified after product release, compromising product sterility. |
| Root cause | Process control |
| Action | Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers. |
| Quantity | 50 units |
| Distribution | US - CA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.