Z-0035-2024Class I

2008T Hd Sys. W/o Cdx W/bibag Bluestar

Name: Z-0035-2024 2008T Hd Sys. W/o Cdx W/bibag Bluestar
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2023-09-06
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2023-09-06 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR on 2023-09-06. FDA classified it as Class I and gives the reason as "Potential PCBA leaching from tubing of hemodialysis machines". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0035-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-10-06
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 2008T Hd Sys. W/o Cdx W/bibag Bluestar
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential PCBA leaching from tubing of hemodialysis machines.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent an URGENT MEDICAL DEVICE CORRECTION NOTICE via USPS, dated 09/06/2023. The notice informed consignees that there is a potential for NDL-PCBAs could leach from silicone tubing manufactured with a peroxide-based catalyst. The firm also states that it has been demonstrated that dialysate run through 2008 Series machines used during typical maintenance HD treatments for at least 36 days, cumulatively, showed levels of NDL-PCBAs that were below toxicologically relevant thresholds. Consignees are to contact FMCRTG Technical Service at 1-800-227-2572 to schedule an update to devices to receive the correct tubing or if they have any further questions. Consignees with clinical questions are to contact Global Medical Information and Education Office at 1-855-2309. Consignees are to return the provided response form via fax or mail.
Quantity in commerce: 733 units
Distribution: Domestic: Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0035-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0029-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0030-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0031-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0032-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0033-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0034-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0035-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)