Class 2 Device Recall Chiba Needle Marked

• Date Initiated by Firm: June 19, 2009
• Date Posted: September 20, 2009
• Recall Status: Terminated on October 23, 2009
• Recall Number: Z-1935-2009
• Recall Event ID: 52781
• 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
• Code Information: Lot number 091386.
• Recalling Firm/ Manufacturer: Remington Medical Inc.; 6830 Meadowridge Ct.; Alpharetta GA 30005
• For Additional Information Contact: Lynne Buchanan-Kopp; 770-888-8520
• Manufacturer Reason for Recall: Two unsealed pouches were identified after product release, compromising product sterility.
• FDA Determined 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.