FDA Recall
Terminated
BD AutoShield Pen Needle (Re order Number : 329300)
Recall: Z-0838-2007
·
Initiated April 23, 2007
Recall
- Recall Number
- Z-0838-2007
- Event Number
- 37900
- Firm
- Becton Dickinson & Company
- FEI Number
- 2243072
- Product Code
- FMI
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 23, 2007
- Posted
- May 24, 2007
- Terminated
- April 16, 2008
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815
Description
BD AutoShield Pen Needle (Re order Number : 329300)
Reason
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)
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.
Distribution
Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
Quantity
496,200 units