Class 2 Device Recall TemnoChiba Soft Tissue Fine Aspiration Needle

• Date Initiated by Firm: June 02, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on September 08, 2003
• Recall Number: Z-0942-03
• Recall Event ID: 26426
• 510(K)Number: K962907
• Product Classification: Instrument, Biopsy - Product Code KNW
• Product: Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic
• Code Information: Catalog number CHI1815, lot D03AB0594
• FEI Number: 3001236905
• Recalling Firm/ Manufacturer: Cardinal Health; 1430 Waukegan Rd; McGaw Park IL 60085
• For Additional Information Contact: Quality Systems Professional Services; 800-292-9332
• Manufacturer Reason for Recall: The product was shipped prior to being sterilized.
• FDA Determined Cause: Other
• Action: Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement.
• Quantity in Commerce: 50 needles
• Distribution: Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = KNW