Medical Device Recall: Z-0019-04

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

Recall Action Class: N/A Date Initiated: 2003-08-18 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-04.

Recall Res Number
Z-0019-04
Recalling Firm / Manufacturer
Cryolife Inc
FEI Number
3001451326
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-08-18
Date Posted
2003-10-15
Date Terminated
2003-10-15
Product Code
MIE
Event Number
27051
Product Quantity
1 unit
Product Description CryoValve, Pulmonary Valve & Conduit SG
Reason for Recall The heart valve procurement exceeded the warm ischemic time criteria.
Action Details The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003.
Distribution Pattern Tissue was distributed to one physician in CA.
Code Information / Serial Numbers Donor #61354, Device #7693941, Model #SGPV00

Related Establishments / Registrations

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