Z-1417-2009

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

Name: Z-1417-2009 CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta...
Creator: Remington Medical Inc.
Published: 2009-04-06
License: https://open.fda.gov/license/

Remington Medical / initiated 2009-04-06 / Terminated / root cause: packaging

FDA source

Remington Medical Inc. began a recall of 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... on 2009-04-06. The reason FDA records is "Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1417-2009
Status: Terminated
Initiated: 2009-04-06
Posted: 2009-05-26
Terminated: 2009-05-27
Recalling firm: Remington Medical
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.
Product code: GDM Needle, Aspiration And Injection, Reusable
Reason for recall: Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Root cause tag: packaging
FDA root 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.
Product codes and lots: Lot Number 083665.

Product code GDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)