Z-0838-2007
BD AutoShield Pen Needle (Re order Number : 329300)
Becton Dickinson & Co / initiated 2007-04-23 / Terminated / root cause: labeling and UDI
Becton Dickinson & Company began a recall of BD AutoShield Pen Needle (Re order Number : 329300) on . The reason FDA records is "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)". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0838-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Becton Dickinson & Co
- Product
- BD AutoShield Pen Needle (Re order Number : 329300)
- Product code
- FMI Needle, Hypodermic, Single Lumen
- 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)
- Root cause tag
- labeling and UDI
- FDA 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 in commerce
- 496,200 units
- Distribution
- Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
- Product codes and lots
- Reorder Number 329300
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