BEUDAMED
    FDA Enforcement Class II Terminated

    Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

    Recall: Z-1748-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1748-2014
    Event ID
    68081
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sakura Finetek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    April 16, 2014
    Classification Date
    June 10, 2014
    Termination Date
    September 2, 2014
    Address
    1750 W 214th St, N/A, Torrance, CA, 90501-2857, United States

    Description

    Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

    Reason

    This Lot has variations in melting temperature.

    Code Info

    Product Code: 7052. Lot Number: 263922.

    Distribution

    Nationwide Distribution.

    Quantity

    115