Class 2 Device Recall SafetyLok Blood Collection Set

• Date Initiated by Firm: March 20, 2007
• Date Posted: May 10, 2007
• Recall Status: Terminated on July 25, 2007
• Recall Number: Z-0777-2007
• Recall Event ID: 37710
• 510(K)Number: K980414
• Product Classification: Blood Collection Set - Product Code JKA
• Product: BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.
• Code Information: Catalog # 368652 Lot Numbers: 5236082; 5236093; 5236095.
• FEI Number: 2243072
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: David Pieratos; 201-847-4548
• Manufacturer Reason for Recall: The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.
• FDA Determined Cause: Other
• Action: Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.
• Quantity in Commerce: 147,200 units
• Distribution: Nationwide and Canada.
• 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