BEUDAMED
    FDA Enforcement Class II Terminated

    MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.

    Recall: Z-2440-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2440-2018
    Event ID
    80374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canadian Hospital Specialties
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    June 11, 2018
    Classification Date
    July 18, 2018
    Termination Date
    March 13, 2019
    Address
    2760 Brighton Rd, Oakville, N/A, Canada

    Description

    MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.

    Reason

    The product may be packaged with the incorrect length of feeding tube as labeled.

    Code Info

    Lot #135137

    Distribution

    Distribution was made to GA. The foreign recalling firm also distributed product to Canada.

    Quantity

    10/10-tube cases