Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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