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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve

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 Class 2 Device Recall CryoValvesee related information
Date Initiated by FirmJuly 10, 2003
Date PostedJuly 22, 2003
Recall Status1 Terminated 3 on May 12, 2004
Recall NumberZ-1038-03
Recall Event ID 26693
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve, Synegraft Pulmonary Valve & Conduit
Code Information Donor #65019, Serial #7925364, Model #SGPV00
FEI Number 3001451326
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information ContactSylvie Verdon
770-419-3355
Manufacturer Reason
for Recall		Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
FDA Determined
Cause 2		Other
ActionThe physician was notified by letter on 7/10/2003.
Quantity in Commerce1 tissue
DistributionThe tissue was distributed to one physician in CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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