BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1748-2014 · Initiated April 16, 2014

    Recall

    Recall Number
    Z-1748-2014
    Event Number
    68081
    Firm
    Sakura Finetek USA Inc
    FEI Number
    2083544
    Product Code
    KEO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 16, 2014
    Posted
    June 10, 2014
    Terminated
    September 2, 2014
    Address
    1750 W 214th St, Torrance, CA, 90501-2857

    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.

    Action

    Customer notifications sent via e-mail letter. The letter titled "PRODUCT RECALL" dated 04/17/2014 informed customers (of Lot 263922), informed customers of the recall by providing the following information: product name, code, lot number, reason for recall, requested actions, contact information and an "FIELD CORRECTION EFFECTIVENESS CHECK" form.

    Distribution

    Nationwide Distribution.

    Quantity

    115