Z-0619-2009
BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile...
Becton Dickinson & Co / initiated 2008-11-24 / Terminated / root cause: packaging
Becton Dickinson & Company began a recall of BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in... on . The reason FDA records is "Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0619-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Becton Dickinson & Co
- Product
- BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.
- Product code
- MEG Syringe, Antistick
- Reason for recall
- Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.
- Root cause tag
- packaging
- FDA root cause
- Incorrect or no expiration date
- Action
- Recall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.
- Quantity in commerce
- 334,400 units
- Distribution
- GA, KS, OH, MO, FL, PA, KY and NY.
- Product codes and lots
- Lot number 8078251
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
