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U.S. Department of Health and Human Services

Class 2 Device Recall Remington Medical

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  Class 2 Device Recall Remington Medical see related information
Date Initiated by Firm April 06, 2009
Date Posted May 26, 2009
Recall Status1 Terminated 3 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/
Remington Medical Inc.
6830 Meadowridge Ct.
Alpharetta GA 30005
For Additional Information Contact Lynne Buchanan-Kopp
Manufacturer Reason
for Recall
Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
FDA Determined
Cause 2
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.