BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0720-04 · Initiated February 27, 2004

    Recall

    Recall Number
    Z-0720-04
    Event Number
    28411
    FEI Number
    2110898
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2004
    Posted
    July 20, 2004
    Terminated
    December 28, 2006
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, St Paul, MN, 55411

    Description

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

    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.

    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.

    Distribution

    Nationwide throughout the United States and worldwide.

    Quantity

    90,000 ampoules