Medical Device Recall: Z-0002-04

FDA Recalls dataset · Firm: Bard Peripheral Vascular Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-08-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-04.

Recall Res Number
Z-0002-04
Recalling Firm / Manufacturer
Bard Peripheral Vascular Inc
FEI Number
2020394
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-08-20
Date Posted
2003-10-15
Date Terminated
2005-11-21
Product Code
GBR
Event Number
27393
Product Quantity
14 units
Product Description Opti-Plast Balloon Dilatation Catheters
Reason for Recall Product intended for distribution outside USA was distributed without premarket notification requirements being met.
Action Details The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
Distribution Pattern OH, AL, MS, LA, VA
Code Information / Serial Numbers Models:  XT75410, XT100410, XT120410

Related Establishments / Registrations

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