Z-0525-03

Pulmonary heart valve allograft, human tissue for transplantation

Name: Z-0525-03 Pulmonary heart valve allograft, human tissue for transplantation
Creator: LifeNet
Published: 2002-12-19
License: https://open.fda.gov/license/

Lifenet / initiated 2002-12-19 / Terminated

FDA source

LifeNet began a recall of Pulmonary heart valve allograft, human tissue for transplantation on 2002-12-19. The reason FDA records is "Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0525-03
Status: Terminated
Initiated: 2002-12-19
Posted: 2003-02-01
Terminated: 2003-01-27
Recalling firm: Lifenet
Product: Pulmonary heart valve allograft, human tissue for transplantation.
Product code: MIE Heart-Valve, Allograft
Reason for recall: Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
FDA root cause: Other
Action: Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned.
Quantity in commerce: 1 valve
Distribution: Product was shipped to one hospital in NY
Product codes and lots: 01-0293HV-02

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)