Medical Device Recall: Z-0026-05

FDA Recalls dataset · Firm: Cryolife Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-07-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0026-05.

Recall Res Number
Z-0026-05
Recalling Firm / Manufacturer
Cryolife Inc
FEI Number
3001451326
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-07-15
Date Posted
2004-10-20
Date Terminated
2007-12-31
Product Code
MIE
Event Number
30191
Product Quantity
1 tissue
Product Description CryoValve, Pulmonary Valve & Conduit
Reason for Recall A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
Action Details The physician was notified by letter on 07/15/2004.
Distribution Pattern The tissue was shipped to one physician in CA.
Code Information / Serial Numbers Donor Number: 68668, Serial Number: 8037696, Model Number: PV00

Related Establishments / Registrations

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