Class 2 Device Recall BD 30ml Syringe Luer Lok Tip

• Date Initiated by Firm: November 23, 2009
• Date Posted: December 29, 2009
• Recall Status: Terminated on April 06, 2010
• Recall Number: Z-0586-2010
• Recall Event ID: 53901
• Product Classification: Syringe, piston - Product Code FMF
• Product: BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ.
• Code Information: Catalog Number: 309650; Lot number 9175046
• FEI Number: 2243072
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Greg Morgan; 201-847-4344
• Manufacturer Reason for Recall: Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised.
• FDA Determined Cause: Other
• Action: Recall notification letters were sent to all distributors on 11/23/2009 by Federal Express. BD called all distributors to get customer lists and will start sending letter to customers commencing on December 8, 2009. Questions are directed to BD Customer Service at 1-888-237-2762, Monday  Friday, 8:00 AM  5:00 PM Eastern Time.
• Quantity in Commerce: 166240 units
• Distribution: Distributors nationwide.
• 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.