Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0010-04

Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

Bard Peripheral Vascular Inc / initiated 2003-09-18 / Terminated / root cause: labeling and UDI

Bard Peripheral Vascular began a recall of Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124 on . The reason FDA records is "Mislabeled. 7mm balloon labeled 12mm". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0010-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bard Peripheral Vascular Inc
Product
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Product code
DQY Catheter, Percutaneous
Reason for recall
Mislabeled. 7mm balloon labeled 12mm
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Recall was by letter dated 9/17/2003. Return of the devices is requested under a return authorization number. A fax back form was included to confirm receipt and compliance.
Quantity in commerce
124
Distribution
Nationwide.
Product codes and lots
Lot 93DN0081