BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes

    Recall: Z-2639-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2639-2023
    Event ID
    92915
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 4, 2023
    Initiation Date
    August 22, 2023
    Classification Date
    September 26, 2023
    Address
    3m Center 2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001, United States

    Description

    3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; 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 132¿C and 135¿C.

    Code Info

    UDI/DI: 50707387787276( (shipper); Lot Codes: 33P3EF, exp. 12/27/2024; 33P4ND, exp. 01/01/2025; 33P4NR, exp. 01/01/2025; 33P5CA, exp. 01/03/2025; 33P5XT, exp. 01/06/2025

    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

    172,464 devices