BEUDAMED
    FDA Enforcement Class II Terminated

    Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.

    Recall: Z-2714-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2714-2016
    Event ID
    74862
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Best Sanitizers Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 14, 2016
    Initiation Date
    August 2, 2016
    Classification Date
    September 2, 2016
    Termination Date
    August 18, 2017
    Address
    154 Mullen Dr, Walton, KY, 41094-9606, United States

    Description

    Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.

    Reason

    Certain lots of the acid solution in Acecide-C are degrading faster than normal.

    Code Info

    Lot Numbers: 16012ACE EXP 01/17,16036ACE EXP 02/17, 16015ACE EXP 01/17, 16040ACE EXP 02/17, 16019ACE EXP 01/17, 16043ACE EXP 02/17, 16022ACE EXP 01/17, 16048ACE EXP 02/17, 16026ACE EXP 01/17, 16050ACE EXP 02/17, 16033ACE EXP 02/17. Lot Numbers 16015ACE EXP 01/17, 16036ACE EXP 02/17 were shipped to Olympus in Canada

    Distribution

    Distributed to one (1) account in the state of PA. Distributed to one (1) account in Canada

    Quantity

    3,023 cases USA; 666 cases shipped to Canada (OTC drug there)