Z-0677-03

One heart and pericardium from donor 12144

Name: Z-0677-03 One heart and pericardium from donor 12144
Creator: DCI Donor Services Tissue Services Division
Published: 2002-08-20
License: https://open.fda.gov/license/

DCI Donor Services Tissue Services Division / initiated 2002-08-20 / Terminated / root cause: sterility

FDA source

DCI Donor Services Tissue Services Division began a recall of One heart and pericardium from donor 12144 on 2002-08-20. The reason FDA records is "Human tissue was procured from donor using non-sterile instruments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0677-03
Status: Terminated
Initiated: 2002-08-20
Posted: 2003-03-26
Terminated: 2003-04-08
Recalling firm: DCI Donor Services Tissue Services Division
Product: One heart and pericardium from donor 12144.
Product code: MIE Heart-Valve, Allograft
Reason for recall: Human tissue was procured from donor using non-sterile instruments.
Root cause tag: sterility
FDA root cause: Other
Action: Consignee was notified by memorandum on 8/20/2002.
Quantity in commerce: One heart and pericardium.
Distribution: GA
Product codes and lots: Donor # 12144.

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)