Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall see related information
Date Initiated by Firm September 18, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on December 10, 2004
Recall Number Z-0010-04
Recall Event ID 27357
Product Classification Catheter, Percutaneous - Product Code DQY
Product Conquest Balloon Dilation Catheters

Model/Catalog Number CQ 75124
Code Information Lot 93DN0081
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular
1625 West 3rd Street
Tempe AZ 85281
For Additional Information Contact Mary Edwards
480-303-2640
Manufacturer Reason
for Recall		 Mislabeled. 7mm balloon labeled 12mm
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC 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.
-
-