Z-1056-04

CryoValve Pulmonary Valve SG

Name: Z-1056-04 CryoValve Pulmonary Valve SG
Creator: Cryolife Inc
Published: 2004-06-17
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2004-06-17 / Terminated / root cause: manufacturing process

FDA source

Cryolife Inc began a recall of CryoValve Pulmonary Valve SG on 2004-06-17. The reason FDA records is "The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1056-04
Status: Terminated
Initiated: 2004-06-17
Posted: 2004-07-20
Terminated: 2005-03-07
Recalling firm: Artivion, Inc.
Product: CryoValve Pulmonary Valve SG
Product code: MIE Heart-Valve, Allograft
Reason for recall: The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified by letter on 06/17/2004 and 06/18/2004.
Quantity in commerce: 1 unit
Distribution: CA, OH, OR, PA.
Product codes and lots: Device Donor number: 64212, Serial Number: 7887101, Model Number: SGPV10

Product code MIE

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)