BD AutoShield Pen Needle (Re order Number : 329300)
FDA device recall Z-0838-2007 · posted 2007-05-24 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- 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)
- Action taken
- 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
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 496,200 units
- Distribution
- Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
- Date initiated
- 2007-04-23
- Date posted
- 2007-05-24
- Date terminated
- 2008-04-16
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD AUTOSHIELD PEN NEEDLE (K060007) | Becton, Dickinson & CO | 2006-03-23 |