Opti-Plast Balloon Dilatation Catheters
FDA device recall Z-0002-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- Product intended for distribution outside USA was distributed without premarket notification requirements being met.
- Action taken
- The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBR
- Quantity affected
- 14 units
- Distribution
- OH, AL, MS, LA, VA
- Date initiated
- 2003-08-20
- Date posted
- 2003-10-15
- Date terminated
- 2005-11-21
- Location
- Tempe, AZ
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