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Class 2 Device Recall BD AutoShield Pen Needle |
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Date Initiated by Firm |
April 23, 2007 |
Date Posted |
May 24, 2007 |
Recall Status1 |
Terminated 3 on April 16, 2008 |
Recall Number |
Z-0838-2007 |
Recall Event ID |
37900 |
510(K)Number |
K060007
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Product Classification |
Hypodermic Needle - Product Code FMI
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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
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For Additional Information Contact |
Wafa Al-Rimawi 201-847-6795
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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)
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = BECTON DICKINSON & CO.
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