Class 2 Device Recall Becton Dickinson

• Date Initiated by Firm: April 09, 2007
• Date Posted: May 24, 2007
• Recall Status: Terminated on August 09, 2007
• Recall Number: Z-0813-2007
• Recall Event ID: 37871
• 510(K)Number: K980987
• Product Classification: syringe - Product Code FMF
• Product: BD 5ml Syringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free
• Code Information: Lot number 7002604 Ref 309703
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Greg Morgan; 210-847-4344
• Manufacturer Reason for Recall: Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.
• FDA Determined Cause: Other
• Action: Recall communications were sent on April 2, 2007 and May 3, 2007 by UPS second day air to all direct consignees and potential customers.
• Quantity in Commerce: 174,300 units
• Distribution: 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.

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