Class 2 Device Recall

• Date Initiated by Firm: July 11, 2005
• Date Posted: August 30, 2005
• Recall Status: Terminated on June 29, 2006
• Recall Number: Z-1423-05
• Recall Event ID: 32808
• 510(K)Number: K990188
• Product Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
• Product: BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.
• Code Information: Catalog #364880, Lot #5076799, Exp 2/2008; #50076797, exp. 2/2008; #5976798, Exp 2/2008; #5098260, Exp 3/2008; #5112114, Exp 3/2008.
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Kevin Nolan; 201-847 Ext. 5651
• Manufacturer Reason for Recall: Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
• FDA Determined Cause: Other
• Action: A customer communication was sent by first class mail on 7/26/05, advising all consignees of the problem. The letter asks each customer to immediately examine their inventory for affected lot numbers, return product from affected lots using enclosed label and packing slip, and to notify all of their affected customers to alert them to the situation.
• Quantity in Commerce: 641200 eaches
• Distribution: Worldwide
• 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 = JKA