BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

    Recall: Z-3107-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3107-2024
    Event ID
    95128
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 18, 2024
    Initiation Date
    June 27, 2024
    Classification Date
    September 11, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

    Reason

    Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

    Code Info

    a) DYK1002174I: UDI/DI case 40195327332403, UDI/DI each 10195327332402; Lot Numbers: 24CLA959; b) DYKE1558B: UDI/DI case 40195327258512, UDI/DI each 10195327258511; Lot Numbers: 24DMA783, 24BMG878, 23LMG790; c) DYKE1804A: UDI/DI case 40195327023035, UDI/DI each 10195327023034; Lot Numbers: 24BMI437, 24AME311, 23LMC958; d) DYNJ900714C: UDI/DI case 40193489951364, UDI/DI each 10193489951363; Lot Numbers: 24FBC609; e) DYNJ905472B: UDI/DI case 40195327200573, UDI/DI each 10195327200572; Lot Numbers: 24BBS291; f) DYNJ908096A: UDI/DI case 40195327507061, UDI/DI each 10195327507060; Lot Numbers: 24ABX948, 24ABB080

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Panama.

    Quantity

    1,646 units