Recall Z-0838-2007 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD AutoShield Pen Needle (Re order Number : 329300)
| Date | May 24, 2007 (initiated Apr 23, 2007) |
| Status | Terminated |
| 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) |
| Root cause | 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 | 496,200 units |
| Distribution | Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060007 | BD AUTOSHIELD PEN NEEDLE Becton, Dickinson & CO, Mar 23, 2006 |