FDA Recall
Terminated
Opti-Plast Balloon Dilatation Catheters
Recall: Z-0002-04
·
Initiated August 20, 2003
Recall
- Recall Number
- Z-0002-04
- Event Number
- 27393
- Firm
- Bard Peripheral Vascular Inc
- FEI Number
- 2020394
- Product Code
- GBR
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 20, 2003
- Posted
- October 15, 2003
- Terminated
- November 21, 2005
- Address
- 1625 W 3rd St, Tempe, AZ, 85281-2438
Description
Opti-Plast Balloon Dilatation Catheters
Reason
Product intended for distribution outside USA was distributed without premarket notification requirements being met.
Action
The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
Distribution
OH, AL, MS, LA, VA
Quantity
14 units