Z-1297-03

CryoValve, Pulmonary Valve & Conduit

Name: Z-1297-03 CryoValve, Pulmonary Valve & Conduit
Creator: Cryolife Inc
Published: 2003-09-10
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-09-10 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve, Pulmonary Valve & Conduit on 2003-09-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1297-03
Status: Terminated
Initiated: 2003-09-10
Posted: 2003-10-15
Terminated: 2004-05-06
Recalling firm: Artivion, Inc.
Product: CryoValve, Pulmonary Valve & Conduit
Product code: NJK Valve, Pulmonary
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 root cause: Other
Action: Consignees were notified by letter on 09/10/2003 and 09/12/2003.
Quantity in commerce: 1 unit
Distribution: The tissues were distributed to one hospital in CA and one physician in MN.
Product codes and lots: Donor #69884, Serial #8062341, Model #PV00.

Product code NJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)