BEUDAMED
    FDA Recall Terminated

    TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage

    Recall: Z-0271-2012 · Initiated March 25, 2011

    Recall

    Recall Number
    Z-0271-2012
    Event Number
    60374
    Firm
    Ethox International, Inc.
    FEI Number
    1314417
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 25, 2011
    Posted
    November 22, 2011
    Terminated
    November 28, 2011
    Address
    251 Seneca Street, Buffalo, NY, 14204

    Description

    TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage

    Reason

    Ethox Tum-E-Vac Gastric Lavage Kit #2075, Lot Number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton was labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.

    Action

    Ethox International, Inc. sent an "URGENT DEVICE RECALL" letter dated March 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine if they have the affected product. Customers are to return the affected product to the firm by using UPS account 128959. Customers will be reimbursed for the returned goods. Additionally, a response form was enclosed for customers to complete and return. Contact the firm at (716) 842-4000 for questions regarding this recall.

    Distribution

    Nationwide Distribution-including the states of California, Connecticut, Illinois, Ohio, and Virginia.

    Quantity

    130 units