BEUDAMED
    FDA Recall Open, Classified

    3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes

    Recall: Z-2638-2023 · Initiated August 22, 2023

    Recall

    Recall Number
    Z-2638-2023
    Event Number
    92915
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    FRC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 22, 2023
    Posted
    September 26, 2023
    Address
    2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001

    Description

    3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes

    Reason

    Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C.

    Action

    3M issued an Urgent product recall notice to its consignees on 08/24/2023 by email and US mail. The notice explained the problem with the product and requested the following: Discontinue distribution of the product and dispose of the product. Distributors were directed to notify their customers. The firm is offering replacement with the return of the completed response form.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

    Quantity

    33504 devices