Recalls / —

—#29801

Product

Opti-Plast Balloon Dilatation Catheters

FDA product code

GBR

Affected lot / code info

Models:  XT75410, XT100410, XT120410

Why it was recalled

Product intended for distribution outside USA was distributed without premarket notification requirements being met.

Root cause (FDA determination)

Other

Action the firm took

The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.

Recalling firm

Firm

Bard Peripheral Vascular Inc

Address

1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern

OH, AL, MS, LA, VA

Timeline

Recall initiated

2003-08-20

Posted by FDA

2003-10-15

Terminated

2005-11-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.