Opti-Plast Balloon Dilatation Catheters
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- August 20, 2003
- Posted
- October 15, 2003
- Terminated
- November 21, 2005
- Recall Number
- Z-0002-04
- Quantity
- 14 units
- Firm Location
- Tempe, AZ
Reason for Recall
Product intended for distribution outside USA was distributed without premarket notification requirements being met.
Distribution
OH, AL, MS, LA, VA
Lot / Code Info
Models: XT75410, XT100410, XT120410
Root Cause
Other
Action Taken
The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
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