BEUDAMED
    FDA Recall Terminated

    CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition Product Usage: For delivery of enteral nutrition

    Recall: Z-1080-2012 · Initiated January 26, 2012

    Recall

    Recall Number
    Z-1080-2012
    Event Number
    61036
    Firm
    Corpak Med Systems
    FEI Number
    3011270181
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 26, 2012
    Posted
    February 22, 2012
    Terminated
    March 21, 2012
    Address
    1001 Asbury Dr, Buffalo Grove, IL, 60089

    Description

    CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition Product Usage: For delivery of enteral nutrition

    Reason

    The wrong size Twoomey adapter was packaged with the Jejunal tube.

    Action

    Corpak MedSystems telephoned customers on January 26, 2012 and sent a follow-up Recall Notification letter dated January 27, 2012 via e-mail reiterating the telephone conversations. Customers were informed of the urgent product recall, the problem and the actions to be taken. Customers were instructed to inspect inventory, segregate any affected product and contact Corpak at 1-800-323-6305 to arrange for the return and replacement of the units found. Customers were advised to complete and return the enclosed acknowledgment form, indicating the number of affected units found in their inventory. Distributors were requested to notify their customers. For questions contact Corpak MedSytems at 1-800-403-3400.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Tennessee, Utah and the countries of to Sweden and New Zealand.

    Quantity

    145 units