FDA Medical Device Recalls (openFDA)
3m Health Care: 3M Attest 1264P Biological Indicators, in boxes of 25 per box
- Recall number
- Z-0237-04
- Recalling firm
- 3m Health Care
- Product
- 3M Attest 1264P Biological Indicators, in boxes of 25 per box
- Status
- Terminated
- Initiated
- 2003-10-24
- Posted
- 2003-12-18
- Terminated
- 2005-02-09
- Reason
- 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
- 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
- 1844 boxes of 25 biological indicators per box
- Distribution
- The product was distributed nationwide in the United States and worldwide.
- Lot, serial or model codes
- Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 2110898
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28