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
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