FDA Device

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.

Hazard

Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.

What You Should Do

Remedy

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.

Products

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.
Brand
Remington Medical Inc.
UPC
Lot Number 083665.

Units Affected

60 units