Class 2 Device Recall BD AutoShield Pen Needle

• Date Initiated by Firm: April 23, 2007
• Date Posted: May 24, 2007
• Recall Status: Terminated on April 16, 2008
• Recall Number: Z-0838-2007
• Recall Event ID: 37900
• 510(K)Number: K060007
• Product Classification: Hypodermic Needle - Product Code FMI
• Product: BD AutoShield Pen Needle (Re order Number : 329300)
• Code Information: Reorder Number 329300
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Wafa Al-Rimawi; 201-847-6795
• Manufacturer Reason for Recall: Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)
• FDA Determined Cause: Other
• Action: April 23, 2007, Recall letters were sent via UPS 2nd day air and/or hand delivered to all direct consignees and potential customers of the product.
• Quantity in Commerce: 496,200 units
• Distribution: Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
• 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 = FMI and Original Applicant = BECTON DICKINSON & CO.