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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 17, 2005
Date Posted June 01, 2005
Recall Status1 Terminated 3 on June 01, 2005
Recall Number Z-0860-05
Recall Event ID 32127
Product Classification Heart-Valve, Allograft - Product Code MIE
Product Pulmonary Valve & Conduit
Code Information Donor #77647, Serial #8471383, Model #PV00
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
Manufacturer Reason
for Recall		 Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
FDA Determined
Cause 2		 Other
Action Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed.
Quantity in Commerce 1 unit
Distribution IL, MT
Total Product Life Cycle TPLC 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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