BEUDAMED
    FDA Enforcement Class II Terminated

    MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.

    Recall: Z-0725-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0725-2019
    Event ID
    81763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canadian Hospital Specialties
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 23, 2019
    Initiation Date
    December 1, 2018
    Classification Date
    January 11, 2019
    Termination Date
    April 2, 2021
    Address
    2760 Brighton Rd, Oakville, N/A, Canada

    Description

    MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.

    Reason

    The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.

    Code Info

    Lot 139457

    Distribution

    US in the states of TN

    Quantity

    75 cases of 10