BEUDAMED
    FDA Enforcement Class II Terminated

    ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.

    Recall: Z-1104-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1104-2017
    Event ID
    76101
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mesa Laboratories Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    April 4, 2016
    Classification Date
    January 26, 2017
    Termination Date
    January 26, 2017
    Address
    PO Box 27261, 8607 Park Dr, Omaha, NE, 68127-3623, United States

    Description

    ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.

    Reason

    Product resistance has fallen outside of label claim within expiry.

    Code Info

    Lot # 637, exp. date 12/2016

    Distribution

    Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.

    Quantity

    328/ 50-count/ boxes; 16,400 individual units