FDA Device

Opti-Plast Balloon Dilatation Catheters

Hazard

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

What You Should Do

Remedy

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

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Products

Opti-Plast Balloon Dilatation Catheters
Brand
Bard Peripheral Vascular Inc
UPC
Models:  XT75410, XT100410, XT120410

Units Affected

14 units

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