Agency classClass IOur severity:Severe FDA (Devices)·Z-0029-2024·Announced 2023-10-18

Hemodialysis machines recalled for potential printed circuit board contamination

Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I medical device recall, the most serious category. Per the recall severity rubric, FDA Class I classification requires a minimum severity score of 4 (Severe), indicating serious potential harm to patients.

Plain-English summary

Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System without CDX due to potential printed circuit board assembly (PCBA) material leaching from hemodialysis machine tubing.

The FDA classified this as a Class I recall, its most serious medical device recall category. Class I recalls indicate that use of the product will cause serious harm or death, or that there is a reasonable probability that it will.

The affected units were distributed nationwide domestically. The recall involves specific serial numbers across multiple production batches as documented in the FDA's Medical Device Recall database.

Patients and healthcare providers using affected machines should verify their device serial numbers against the FDA's official recall list. Those with affected units should contact Fresenius Medical Care Holdings, Inc. for remediation information.

The recalled product

Product: 2008T Hemodialysis System without CDX
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Hemodialysis Equipment
Hazard: pcba-leaching
device-contamination
Affected units: 733

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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Same hazard · pcba leaching