BEUDAMED
    FDA Enforcement Class I Ongoing

    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

    Recall: Z-0035-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0035-2024
    Event ID
    92788
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 18, 2023
    Initiation Date
    September 6, 2023
    Classification Date
    October 6, 2023
    Address
    920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States

    Description

    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

    Reason

    Potential PCBA leaching from tubing of hemodialysis machines.

    Code Info

    Model No: 191130; UDI-DI: 00840861102112; Serial No. 1T0S261032, 1T0S261004, 1T0S261029, 1T0S260995, 1T0S260937, 1T0S260739, 1T0S260687, 1T0S260573, 2T0S263945, 2T0S263947, 2T0S263959, 2T0S263924, 2T0S263962, 2T0S263956, 2T0S263951, 2T0S263950, 2T0S263707, 2T0S263692, 2T0S263690, 2T0S263682, 2T0S263700, 2T0S264084, 2T0S263944, 2T0S263954, 2T0S263957, 2T0S264087, 2T0S264144, 2T0S264132, 2T0S264073, 2T0S264139, 2T0S264061, 2T0S263979, 2T0S263983, 2T0S263973, 2T0S263977, 2T0S263989, 2T0S263938, 2T0S263960, 2T0S263943, 2T0S263968, 2T0S263941, 2T0S263940, 2T0S263939, 2T0S263934, 2T0S263933, 2T0S263932, 2T0S263931, 2T0S263930, 2T0S263927, 2T0S263926, 2T0S263925, 2T0S263923, 2T0S263922, 2T0S263921, 2T0S263920, 2T0S263919, 2T0S263918, 2T0S263916, 2T0S263912, 2T0S263911, 2T0S263910, 2T0S263792, 2T0S263791, 2T0S263784, 2T0S263780, 2T0S263778, 2T0S263776, 2T0S263775, 2T0S263771, 2T0S263769, 2T0S263767, 2T0S263754, 2T0S263752, 2T0S263721, 2T0S263715, 2T0S263711, 2T0S263703, 2T0S263948, 2T0S263718, 2T0S263935, 2T0S263946, 2T0S263953, 2T0S263785, 2T0S263710, 2T0S263615, 2T0S264240, 2T0S264210, 2T0S264246, 2T0S264220, 2T0S264243, 2T0S264250, 2T0S264211, 2T0S264221, 2T0S264247, 2T0S264255, 2T0S264245, 2T0S264248, 2T0S264241, 2T0S264249, 2T0S264264, 2T0S264258, 2T0S264232, 2T0S264234, 2T0S264235, 2T0S264259, 2T0S264265, 2T0S264263, 2T0S264260, 2T0S264227, 2T0S264226, 2T0S264229, 2T0S264224, 2T0S264230, 2T0S264231, 2T0S264236, 2T0S264256, 2T0S264239, 1T0S260442, 1T0S260555, 1T0S260595, 1T0S260603, 1T0S260606, 1T0S260607, 1T0S260609, 1T0S260610, 1T0S260611, 1T0S260612, 1T0S260613, 1T0S260614, 1T0S260615, 1T0S260619, 1T0S260622, 1T0S260627, 1T0S260635, 1T0S260639, 1T0S260641, 1T0S260650, 1T0S260661, 1T0S260678, 1T0S260724, 1T0S260760, 1T0S260768, 1T0S260771, 1T0S260774, 1T0S260783, 2T0S262650, 2T0S262689, 2T0S262694, 2T0S262698, 2T0S262712, 2T0S263634, 2T0S263821, 2T0S263836, 2T0S266610, 2T0S266633, 2T0S264058, 2T0S264081, 8T0S226502, 8T0S229547, 8T0S229559, 8T0S229563, 8T0S229570, 8T0S229574, 8T0S229575, 8T0S229582, 8T0S229583, 8T0S229586, 8T0S229590, 8T0S229601, 8T0S233656, 8T0S233657, 2T0S264214, 0T0S251261, 0T0S251286, 0T0S251319, 0T0S251792, 0T0S251811, 0T0S251809, 0T0S251810, 9T0S236793, 0T0S251309, 2T0S263496, 2T0S263531, 0T0S248136, 0T0S248150, 0T0S248148, 0T0S248156, 1T0S260397, 1T0S260419, 1T0S260349, 1T0S260427, 1T0S260346, 1T0S260433, 1T0S260352, 1T0S260358, 1T0S260370, 1T0S260429, 1T0S260374, 1T0S260367, 1T0S260423, 1T0S260616, 1T0S260637, 1T0S260707, 1T0S260823, 1T0S260405, 1T0S260424, 1T0S260311.

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    733 units