BEUDAMED
    FDA Enforcement Class II Terminated

    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.

    Recall: Z-1994-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1994-2013
    Event ID
    65866
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Getinge USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    August 2, 2013
    Classification Date
    August 21, 2013
    Termination Date
    February 23, 2017
    Address
    1777 E Henrietta Rd, N/A, Rochester, NY, 14623-3133, United States

    Description

    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.

    Reason

    AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.

    Code Info

    LOT SR-430 (Expiration 02/06/2014)

    Distribution

    Worldwide Distribution - USA and the country of Canada.

    Quantity

    Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)