RecallDepth

Opti-Plast Balloon Dilatation Catheters

Company
Bard Peripheral Vascular Inc
Recall Initiated
August 20, 2003
Posted
October 15, 2003
Terminated
November 21, 2005
Recall Number
Z-0002-04
Quantity
14 units
Firm Location
Tempe, AZ

Reason for Recall

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

Distribution

OH, AL, MS, LA, VA

Lot / Code Info

Models:  XT75410, XT100410, XT120410

Root Cause

Other

Action Taken

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

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