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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 FirmSeptember 10, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on May 06, 2004
Recall NumberZ-1297-03
Recall Event ID 27280
Product Classification Valve, Pulmonary - Product Code NJK
ProductCryoValve, Pulmonary Valve & Conduit
Code Information Donor #69884, Serial #8062341, Model #PV00.
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information ContactSylvie L. Verdon
770-419-3355
Manufacturer Reason
for Recall		Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on 09/10/2003 and 09/12/2003.
Quantity in Commerce1 unit
DistributionThe tissues were distributed to one hospital in CA and one physician in MN.
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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