BD AutoShield Pen Needle (Re order Number : 329300)
FDA Recall Z-0838-2007 · Posted 2007-05-24
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMI
Date Initiated2007-04-23
Date Terminated2008-04-16
Product Quantity496,200 units
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)
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.