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U.S. Department of Health and Human Services

Class 2 Device Recall Remington Medical

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 Class 2 Recall
Remington Medical
see related information
Date Posted May 26, 2009
Recall Status1 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, Georgia 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 2
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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