# FDA recall Z-3194-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2018-07-13.

## 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.

## Reason for recall

In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.

## Distribution

US Nationwide in the states of :  CA, CT, MI, NC, and NY.

## Key facts

- **Recall number:** Z-3194-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-13
- **Report date:** 2018-09-26
- **Termination date:** 2019-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3194-2018

## Citation

> AI Analytics. FDA recall Z-3194-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3194-2018. Source: US FDA. Licensed CC0.

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