Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0035-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 6, 2023

Date Posted: October 18, 2023

Recall Number: Z-0035-2024

Event ID: 92788

Reason for Recall:

Potential PCBA leaching from tubing of hemodialysis machines.

Status: Ongoing

Product Quantity: 733 units

Code Information:

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 Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated