Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0719-2007

BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, NJ Made in USA

Becton Dickinson & Co / initiated 2007-02-15 / Terminated / root cause: labeling and UDI

Becton Dickinson & Company began a recall of BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, NJ Made in USA on . The reason FDA records is "The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0719-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, NJ Made in USA
Product code
FMF Syringe, Piston
Reason for recall
The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Distributors were sent recall notification letters on February 1, 2007 Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007.
Quantity in commerce
332,400 units
Distribution
Nationwide.
Product codes and lots
Reorder number 309650 Lot numbers 6188613, 6188614