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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 FirmAugust 20, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on November 21, 2005
Recall NumberZ-0002-04
Recall Event ID 27393
Product Classification unknown device name - Product Code GBR
ProductOpti-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 ContactMary 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
ActionThe firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
Quantity in Commerce14 units
DistributionOH, 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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