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U.S. Department of Health and Human Services

Class 2 Device Recall BD AutoShield Pen Needle

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 Class 2 Recall
BD AutoShield Pen Needle
see related information
Date Posted May 24, 2007
Recall Status1 Terminated on April 16, 2008
Recall Number Z-0838-2007
Recall Event ID 37900
Premarket Notification
510(K) Number
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product BD AutoShield Pen Needle (Re order Number : 329300)
Code Information Reorder Number 329300
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
For Additional Information Contact Wafa Al-Rimawi
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 2
DESIGN: Labeling Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = BECTON DICKINSON & CO.