Agency classClass IOur severity:Critical FDA (Devices)·Z-0028-2024·Announced 2023-10-18

FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall carries a FDA Class I classification, which per FDA regulations indicates a serious health hazard where there is reasonable probability that the product could cause serious adverse health consequences or death.

Plain-English summary

The FDA has issued a Class I recall of the Fresenius 2008T Hemodialysis System with CDX (Model 190713), affecting 703 units distributed nationwide. The recall addresses a potential hazard where printed circuit board assembly (PCBA) materials may leach from the machine's tubing.

Hemodialysis machines are critical medical devices used to filter waste from patient blood. Contamination of the dialysis circuit through material leaching could potentially compromise patient safety. Fresenius Medical Care Holdings, Inc. initiated this recall in response to the identified hazard.

Patients currently using affected units should contact their dialysis provider or Fresenius Medical Care immediately. Healthcare facilities and dialysis centers should review the full FDA recall notice and check whether they operate any units matching the affected serial numbers listed in the recall.

For more information, including the complete list of affected serial numbers and UDI identification, patients and providers can contact Fresenius Medical Care or visit the FDA's official recall database.

The recalled product

Product: 2008T Hemodialysis SYS, with CDX
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Hemodialysis Equipment
Hazard: pcba-leaching
Affected units: 703

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: 190713
UDI-DI: 00840861100897
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