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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 20, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0002-04
Recall Event ID 27393
Product Classification unknown device name - Product Code GBR
Product Opti-Plast Balloon Dilatation Catheters
Code Information Models:  XT75410, XT100410, XT120410
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact Mary Edwards
480-303-2640
Manufacturer Reason
for Recall		 Product intended for distribution outside USA was distributed without premarket notification requirements being met.
FDA Determined
Cause 2		 Other
Action The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
Quantity in Commerce 14 units
Distribution OH, AL, MS, LA, VA
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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