BEUDAMED
    FDA Enforcement Class II 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 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2281-2019
    Event ID
    83374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canadian Hospital Specialties
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    July 16, 2019
    Classification Date
    August 15, 2019
    Termination Date
    May 28, 2025
    Address
    2760 Brighton Rd, N/A, Oakville, N/A, N/A, 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.

    Code Info

    a) 5Fr X 16" (40cm), REF 54-1650R, Lot Number 141487 b) 6.5Fr X16" (40cm), REF 54-1665R, Lot Number 141863 c) 5Fr X 24" (60cm), REF 54-2450R, Lot Numbers: 142844, 143130 d) 6.5Fr X 24" (60cm), REF 54-2465R, Lot Number 142843 e) 8Fr X 24: (60cm), REF 54-2480R, Lot Number 142870 f) 8Fr X 36" (91cm), REF 54-3680R, Lot Number 142842

    Distribution

    GA and TN

    Quantity

    2870 units