FDA Device

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

Hazard

Two unsealed pouches were identified after product release, compromising product sterility.

What You Should Do

Remedy

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.

Products

Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
Brand
Remington Medical Inc.
UPC
Lot number 091386.

Units Affected

50 units