FDA Medical Device Recalls (openFDA)
3M Company / Medical Division: 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box
- Recall number
- Z-0720-04
- Recalling firm
- 3M Company / Medical Division
- Product
- 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box
- Status
- Terminated
- Initiated
- 2004-02-27
- Posted
- 2004-07-20
- Terminated
- 2006-12-28
- Reason
- 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
- 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
- 90,000 ampoules
- Distribution
- Nationwide throughout the United States and worldwide.
- Lot, serial or model codes
- Lot # 2006-01 AN
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 2110898
- Firm city
- St 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