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.
This recall has been terminated (originally issued May 26, 2009).
- Company
- Remington Medical Inc.
- Recall Initiated
- April 6, 2009
- Posted
- May 26, 2009
- Terminated
- May 27, 2009
- Recall Number
- Z-1417-2009
- Quantity
- 60 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Distribution
Nationwide Distribution -- KY and NC.
Lot / Code Info
Lot Number 083665.
Root Cause
Other
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.
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