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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmSeptember 18, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on December 10, 2004
Recall NumberZ-0010-04
Recall Event ID 27357
Product Classification Catheter, Percutaneous - Product Code DQY
ProductConquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Code Information Lot 93DN0081
FEI Number 2020394
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular
1625 West 3rd Street
Tempe AZ 85281
For Additional Information ContactMary Edwards
480-303-2640
Manufacturer Reason
for Recall		Mislabeled. 7mm balloon labeled 12mm
FDA Determined
Cause 2		Other
ActionRecall 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 Commerce124
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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