BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, Pack Number DYNJ900709D; f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C; g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D; h) CYSTO, Pack Number DYNJ908098A; i) MINOR LAPAROTOMY, Pack Number DYNJ908428; j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730

    Recall: Z-3110-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3110-2024
    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) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, Pack Number DYNJ900709D; f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C; g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D; h) CYSTO, Pack Number DYNJ908098A; i) MINOR LAPAROTOMY, Pack Number DYNJ908428; j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730

    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) CDS981509C: UDI/DI case 40195327071173, UDI/DI each 10195327071172, Lot Numbers: 24ABS277; b) CDS981512J: UDI/DI case 4019532759782610195327597825, Lot Numbers: 24BBP412; c) CDS981515D: UDI/DI case 4019532707196810195327071967, Lot Numbers: 23KDC374, 24CDB523, 24EDA579; d) DYNJ900709C: UDI/DI case 4019348995099210193489950991, Lot Numbers: 23LBU953; e) DYNJ900709D: UDI/DI case 4019532763531310195327635312, Lot Numbers: 24CBQ684; f) DYNJ900723C: UDI/DI case 4019348995162310193489951622, Lot Numbers: 24ABL637; g) DYNJ900723D: UDI/DI case 4019532763534410195327635343, Lot Numbers: 24CBG030, 24CBO759, 24EBJ696; h) DYNJ908098A: UDI/DI case 4019532750725210195327507251, Lot Numbers: 24ABY035; i) DYNJ908428: UDI/DI case 4019532707116610195327071165, Lot Numbers: 24ABK094; j) DYNJ909730: UDI/DI case 4019532746453110195327464530, Lot Numbers: 24CBS071, 24EBI597

    Distribution

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

    Quantity

    358 units