Recall Z-0720-04 ยท FRC Indicator, Biological Sterilization Process
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
| Date | Jul 20, 2004 (initiated Feb 27, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.