BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

    Recall: Z-1562-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1562-2026
    Event ID
    98437
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2026
    Initiation Date
    January 30, 2026
    Classification Date
    March 12, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

    Reason

    The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

    Code Info

    1) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22KMG297; 2) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22FMA481; 3) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21IMG797; 4) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMG569; 5) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMB801; 6) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 26ABL637; 7) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467M; 8) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467; 9) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBG183; 10) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25HBF488; 11) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25GBK350; 12) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25FBO822; 13) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBT976; 14) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP602; 15) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP589; 16) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP588; 17) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP587; 18) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP586; 19) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25DBB810; 20) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25ABA001; 21) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24HBM020; 22) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24GBC436; 23) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24FBS256; 24) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBP532; 25) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBA256; 26) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24ABN040; 27) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBP214; 28) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBJ077; 29) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23IBQ646; 30) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23HBU475; 31) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE710; 32) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE709; 33) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23FBF593; 34) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBJ852; 35) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBC954; 36) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 22KBO714; 37) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25IBK435; 38) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBT069; 39) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBO806; 40) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBH137; 41) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25GBA989; 42) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 24LBJ019

    Distribution

    Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.

    Quantity

    2894 units