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.
FDA Recall Z-1417-2009 · Posted 2009-05-26
Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeGDM
Date Initiated2009-04-06
Date Terminated2009-05-27
Product Quantity60 units
Reason for Recall
Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- KY and NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.