Chiba Needle Marked Model: CNM-2308…

Date posted by the FDA

Sept. 20, 2009

Status

Terminated

Filed by

Remington Medical Inc.

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

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

Distribution pattern

US - CA and WI.

Quantity

50 units

Codes and lots

Lot number 091386.

Recall started

June 19, 2009

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-1935-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1935-2009. The agency record governs; check it and the company before acting.