Z-0237-04

3M Attest 1264P Biological Indicators, in boxes of 25 per box

Name: Z-0237-04 3M Attest 1264P Biological Indicators, in boxes of 25 per box
Creator: 3m Health Care
Published: 2003-10-24
License: https://open.fda.gov/license/

3M Company / initiated 2003-10-24 / Terminated / root cause: sterility

FDA source

3m Health Care began a recall of 3M Attest 1264P Biological Indicators, in boxes of 25 per box on 2003-10-24. The reason FDA records is "The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on...". 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-0237-04
Status: Terminated
Initiated: 2003-10-24
Posted: 2003-12-18
Terminated: 2005-02-09
Recalling firm: 3M Company
Product: 3M Attest 1264P Biological Indicators, in boxes of 25 per box
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
Root cause tag: sterility
FDA root cause: Other
Action: The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the product.
Quantity in commerce: 1844 boxes of 25 biological indicators per box
Distribution: The product was distributed nationwide in the United States and worldwide.
Product codes and lots: Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL

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)