Severe FDA (Devices)·Z-3194-2018·Announced 2018-09-26

Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a medical device that could deliver harmful chemicals to patients falls under the 'Severe' category, particularly given the potential for significant injury from chemical exposure during dialysis.

Plain-English summary

Fresenius Medical Care Renal Therapies Group, LLC is recalling 80 units of the 2008T Hemodialysis System with CDX (Part Number 190713), applicable only with the 2008T BlueStar Premium Upgrade Kit (Part Number 191138). These devices are indicated for acute and chronic dialysis therapy.

The recall is due to a software defect that can occur if a power failure or interruption happens during the cleaning and disinfection program while the auto-start feature is enabled. In this scenario, the machine may enter the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. This can result in disinfecting chemicals not being completely removed from the machine before treatment begins, potentially allowing disinfectant to exist in the dialysate delivered to the patient.

The affected units were distributed in the United States in the states of California, Connecticut, Michigan, North Carolina, and New York. Specific serial codes for the affected units are listed in the agency's recall record. Healthcare facilities and patients should contact Fresenius Medical Care for instructions on how to address this issue.

The recalled product

Product: 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Category: Medical Device — Hemodialysis System
Hazard: chemical-exposure
software-defect
Affected units: 80

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)

3T0S119726
3T0S119741
3T0S119747
3T0S119753
3T0S119762
3T0S119775
3T0S119792
3T0S119801
3T0S119806
3T0S119807
3T0S119818
3T0S119823
3T0S119824
3T0S119848
3T0S119863
3T0S119910
3T0S119948
3T0S119965
3T0S119984
3T0S120097

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Fresenius Medical Care Renal Therapies Group, LLC 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 2 products in this recall →

Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC

See all →

High
Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
High
Fresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage
FDA (Devices) · 2019-08-14
Low
Fresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message
FDA (Devices) · 2019-06-12
High
Fresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks
FDA (Devices) · 2018-12-26
High
Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
FDA (Devices) · 2018-12-05

Same hazard · chemical exposure