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2008 Series Hemodialysis Machines recallZ-0029-2024 · Fresenius Medical Care Holdings, Inc. · initiated Sep 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential PCBA leaching from tubing of hemodialysis machines.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0029-2024
Status
Open, Classified
Initiated by the company
Sep 6, 2023
Posted by the FDA
Oct 6, 2023
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
733 units
Product code
KDI
FDA submissions
K150708, K222952, K173972
Distribution
Domestic: Nationwide Distribution.

Product description

2008T Hemodialysis System without CDX

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

Model No: 190858; UDI-DI: 00840861100903; 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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K150708, K222952, K173972 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92788).

Sources and updates

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