Z-0720-04

3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50...

Name: Z-0720-04 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50...
Creator: 3M Company / Medical Division
Published: 2004-02-27
License: https://open.fda.gov/license/

3M Company / initiated 2004-02-27 / Terminated / root cause: sterility

FDA source

3M Company / Medical Division began a recall of 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box on 2004-02-27. The reason FDA records is "The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours". 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-0720-04
Status: Terminated
Initiated: 2004-02-27
Posted: 2004-07-20
Terminated: 2006-12-28
Recalling firm: 3M Company
Product: 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours.
Root cause tag: sterility
FDA root cause: Other
Action: A Product Recall Notice was sent on February 27, 2004 to consignees instructing them to discontinue use of the recalled product and return products to 3M.
Quantity in commerce: 90,000 ampoules
Distribution: Nationwide throughout the United States and worldwide.
Product codes and lots: Lot # 2006-01 AN

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)