Class 2 Device Recall Remington Medical

• Date Initiated by Firm: April 06, 2009
• Date Posted: May 26, 2009
• Recall Status: Terminated on May 27, 2009
• Recall Number: Z-1417-2009
• Recall Event ID: 51962
• Product Classification: Needle, aspiration and injection, reusable - Product Code GDM
• 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.
• Code Information: Lot Number 083665.
• Recalling Firm/ Manufacturer: Remington Medical Inc.; 6830 Meadowridge Ct.; Alpharetta GA 30005
• For Additional Information Contact: Lynne Buchanan-Kopp; 770-888-8520
• Manufacturer Reason for Recall: Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
• FDA Determined 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 in Commerce: 60 units
• Distribution: Nationwide Distribution -- KY and NC.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.