Z-0779-03

N/a

Name: Z-0779-03 N/a
Creator: 3m Health Care
Published: 2002-01-09
License: https://open.fda.gov/license/

3M Company / initiated 2002-01-09 / Terminated / root cause: labeling and UDI

FDA source

3m Health Care began a recall of N/A on 2002-01-09. The reason FDA records is "Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0779-03
Status: Terminated
Initiated: 2002-01-09
Posted: 2003-04-22
Terminated: 2003-05-09
Recalling firm: 3M Company
Product: N/a
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A recall letter was sent to the consignees on January 8, 2002 and requested the return of the product.
Distribution: Distribution was nationwide in the United States. There were no U.S. government accounts.
Product codes and lots: N/A

Product code FRC

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)