# FDA recall Z-0035-2024

> **Fresenius Medical Care Holdings, Inc.** · Class I · device recall initiated 2023-09-06.

## Product

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

## Reason for recall

Potential PCBA leaching from tubing of hemodialysis machines.

## Distribution

Domestic: Nationwide Distribution.

## Key facts

- **Recall number:** Z-0035-2024
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-06
- **Report date:** 2023-10-18

- **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-0035-2024

## Citation

> AI Analytics. FDA recall Z-0035-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0035-2024. Source: US FDA. Licensed CC0.

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