Chiba Needle Marked…

Date posted by the FDA

May 26, 2009

Status

Terminated

Filed by

Remington Medical Inc.

Product

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.

Reason

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

Distribution pattern

Nationwide Distribution -- KY and NC.

Quantity

60 units

Codes and lots

Lot Number 083665.

Recall started

April 6, 2009

Device type

Needle, Aspiration And Injection, Reusable

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-1417-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1417-2009. The agency record governs; check it and the company before acting.