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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 06, 2004
Date PostedNovember 03, 2004
Recall Status1 Terminated 3 on June 29, 2010
Recall NumberZ-0172-05
Recall Event ID 30218
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve, Aortic Valve & Conduit SG
Code Information Donor #60727, Serial #7763406, Model #SGAV00*  Donor #62532, Serial #7818159, Model #SGAV00* Donor #64863, Serial #7865603, Model #SGAV00*  Donor #65932, Serial #8105091, Model #SGAV00 
Recalling Firm/
Manufacturer
Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information ContactMr. P. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
FDA Determined
Cause 2
Other
ActionConsignees were notified by letter on/about May 6, 2004.
Quantity in Commerce4 units
DistributionNationwide, Austria, Canada, Germany
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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