BEUDAMED
    FDA Recall Terminated

    MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

    Recall: Z-2281-2019 · Initiated July 16, 2019

    Recall

    Recall Number
    Z-2281-2019
    Event Number
    83374
    Firm
    Canadian Hospital Specialties
    FEI Number
    3932
    Product Code
    FPD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 16, 2019
    Terminated
    May 28, 2025
    Address
    2760 Brighton Rd, Oakville Canada

    Description

    MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

    Reason

    The firm received a complaint that the connector detached from the feeding tube.

    Action

    The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit.

    Distribution

    GA and TN

    Quantity

    2870 units