BEUDAMED
    FDA Recall Terminated

    V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.

    Recall: Z-2296-2010 · Initiated March 1, 2010

    Recall

    Recall Number
    Z-2296-2010
    Event Number
    56420
    Firm
    He, Inc
    FEI Number
    1000112023
    Product Code
    GDI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 1, 2010
    Posted
    August 27, 2010
    Terminated
    November 2, 2011
    Address
    4052 Indian Creek Rd, Martinez, GA, 30907-2234

    Description

    V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.

    Reason

    Sterile product packaging contains weak seals, which may result in compromised product sterility.

    Action

    Harod Enterprises, Inc. (HE) issued a "Notice of Recall" letter to Cardinal Health/V. Mueller dated March 1, 2010 identifying the issue and affected product. Cardinal Health/V. Mueller will issue a subrecall letter to all their customers (end users) instructing them to discontinue use of the affected lots and return for replacement. and will track all responses and removal of the product from their private label customers. HE will repackage and/or replace all returned product. Consignees can contact Harod Enterprises, Inc. at 1-706-228-5165.

    Distribution

    Nationwide: including state of IL.

    Quantity

    551 cases of 100 packages per case