Z-1935-2009

Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005...

Name: Z-1935-2009 Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005...
Creator: Remington Medical Inc.
Published: 2009-06-19
License: https://open.fda.gov/license/

Remington Medical / initiated 2009-06-19 / Terminated / root cause: manufacturing process

FDA source

Remington Medical Inc. began a recall of Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle on 2009-06-19. The reason FDA records is "Two unsealed pouches were identified after product release, compromising product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1935-2009
Status: Terminated
Initiated: 2009-06-19
Posted: 2009-09-20
Terminated: 2009-10-23
Recalling firm: Remington Medical
Product: Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
Reason for recall: Two unsealed pouches were identified after product release, compromising product sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.
Quantity in commerce: 50 units
Distribution: US - CA and WI.
Product codes and lots: Lot number 091386.

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)