Atlas FDA

CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. T

FDA device recall Z-1417-2009 · posted 2009-05-26 · Terminated

Recall details

Recalling firm
Remington Medical Inc.
Reason for recall
Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
GDM
Quantity affected
60 units
Distribution
Nationwide Distribution -- KY and NC.
Date initiated
2009-04-06
Date posted
2009-05-26
Date terminated
2009-05-27
Location
Alpharetta, GA

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