BEUDAMED
    FDA Recall 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 · Initiated June 11, 2018

    Recall

    Recall Number
    Z-2440-2018
    Event Number
    80374
    Firm
    Canadian Hospital Specialties
    FEI Number
    3932
    Product Code
    FPD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 11, 2018
    Posted
    July 13, 2018
    Terminated
    March 13, 2019
    Address
    2760 Brighton Rd, Oakville 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.

    Action

    The recalling firm issued a letter dated 6/1/2018 via email on 6/11/2018 to formally notify their customer of the reason for recall, discontinue distribution of the product, and complete the enclosed Product Recall Response Form for return via email.

    Distribution

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

    Quantity

    10/10-tube cases