Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0613-06

BD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728

Becton Dickinson & Co / initiated 2006-02-28 / Terminated / root cause: labeling and UDI

BD Opthalmic Systems began a recall of BD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728 on . The reason FDA records is "Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0613-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728
Product code
HNN Knife, Ophthalmic
Reason for recall
Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife
Root cause tag
labeling and UDI
FDA root cause
Other
Action
BD Ophthalmic notifIed customers by telephone on 2/28/06 requesting users to examine product and return mislabeled product.
Quantity in commerce
3430 units
Distribution
Nationwide Foreign: Belgium
Product codes and lots
Lot Number: 5335524