Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
FDA Recall Z-1935-2009 · Posted 2009-09-20
Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Date Initiated2009-06-19
Date Terminated2009-10-23
Product Quantity50 units
Reason for Recall
Two unsealed pouches were identified after product release, compromising product sterility.
Firm 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.
Root Cause
Process control
Distribution Pattern
US - CA and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.