Medical Device Recall: Z-0010-04

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

Recall Action Class: N/A Date Initiated: 2003-09-18 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-04.

Recall Res Number
Z-0010-04
Recalling Firm / Manufacturer
Bard Peripheral Vascular
FEI Number
2020394
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-18
Date Posted
2003-10-15
Date Terminated
2004-12-10
Product Code
DQY
Event Number
27357
Product Quantity
124
Product Description Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Reason for Recall Mislabeled. 7mm balloon labeled 12mm
Action Details Recall was by letter dated 9/17/2003. Return of the devices is requested under a return authorization number. A fax back form was included to confirm receipt and compliance.
Distribution Pattern Nationwide.
Code Information / Serial Numbers Lot 93DN0081

Related Establishments / Registrations

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