Opti-Plast Balloon Dilatation Catheters
FDA Recall Z-0002-04 · Posted 2003-10-15
Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeGBR
Date Initiated2003-08-20
Date Terminated2005-11-21
Product Quantity14 units
Reason for Recall
Product intended for distribution outside USA was distributed without premarket notification requirements being met.
Firm Action
The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
Root Cause
Other
Distribution Pattern
OH, AL, MS, LA, VA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.