BEUDAMED
    FDA Recall Terminated

    Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Mfg. by Viasys MedSystems, Wheeling, IL 60090 Product is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

    Recall: Z-2306-2008 · Initiated June 25, 2008

    Recall

    Recall Number
    Z-2306-2008
    Event Number
    48726
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 25, 2008
    Posted
    September 21, 2008
    Terminated
    September 26, 2008
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Mfg. by Viasys MedSystems, Wheeling, IL 60090 Product is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

    Reason

    The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.

    Action

    Cardinal Health notified the accounts who ordered the affected feeding tubes via letter dated 6/25/08, informing them that the feeding tube may have the wrong male Luer adapter component, which can cause leakage around the tube outside of the body. Upon review of the letter, the accounts were requested to inspect their inventory and immediately destroy any affected product found and to telephone Cardinal Health/VIASYS MedSystems Technical Service at 1-800-323-6305 for arrange for credit. Dealers were requested to notify their customers. Any questions were directed to Cardinal Health/VIASYS MedSystems at 800-403-3400, ext. 3473. The accounts were also requested to complete and fax back the enclosed acknowledgement form indicating if they have any remaining inventory of the recalled scissors or not.

    Distribution

    California, Illinois, Kentucky and Missouri

    Quantity

    807 tubes