Class 2 Device Recall Microtainer Safety Flow Lancets

• Date Initiated by Firm: September 26, 2007
• Date Posted: October 18, 2007
• Recall Status: Terminated on January 15, 2008
• Recall Number: Z-0044-2008
• Recall Event ID: 44940
• Product Classification: Lancets - Product Code FMK
• Product: Microtainer Safety Flow Lancets; Green; Sterile, Use Once and Discard; ; 1.4 mm Blade Length;; 1.0mm Blade Width;; Becton Dickinson Vacutainer Systems;; Becton Dickinson & Company;; Franklin Lakes, NJ 07417
• Code Information: Catalog Number 366356 Lot numbers: 2340296, 2353789, 3007400, 3043001, 3073415, 3100407, 3198493.
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: 201-847-7186
• Manufacturer Reason for Recall: Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.
• FDA Determined Cause: Process design
• Action: Recall communication issued on or about 9/28/2007.
• Quantity in Commerce: 1,476,000 units
• Distribution: Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.
• 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.