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