BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0237-04 · Initiated October 24, 2003

    Recall

    Recall Number
    Z-0237-04
    Event Number
    27465
    FEI Number
    2110898
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 24, 2003
    Posted
    December 18, 2003
    Terminated
    February 9, 2005
    Address
    3m Health Care 3m Center, Saint Paul, MN, 55144-1001

    Description

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

    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.

    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.

    Distribution

    The product was distributed nationwide in the United States and worldwide.

    Quantity

    1844 boxes of 25 biological indicators per box