BEUDAMED
    FDA Recall Terminated

    MAMMOGRAPHY

    Recall: Z-2592-2016 · Initiated October 5, 2015

    Recall

    Recall Number
    Z-2592-2016
    Event Number
    73465
    Firm
    Avid Medical, Inc.
    FEI Number
    1047429
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 5, 2015
    Posted
    August 18, 2016
    Terminated
    January 10, 2017
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    MAMMOGRAPHY

    Reason

    Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.

    Action

    Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 cm) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.

    Distribution

    Recalled product was distributed to 2 states: Virginia and Massachusetts.

    Quantity

    200