# FDA recall Z-0518-2019

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class III · device recall initiated 2018-10-09.

## Product

Fresenius Granuflo Dry Acid Concentrate-  3K 2.5 Ca 1 Mg 16.5 GAL    Catalog Number: OFD3251-3B  for hemodialysis

## Reason for recall

Discolored powder has confirmed the presence of a foreign substance

## Distribution

Distribution US nationwide and Mexico

## Key facts

- **Recall number:** Z-0518-2019
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-09
- **Report date:** 2018-12-05
- **Termination date:** 2021-08-05

- **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-0518-2019

## Citation

> AI Analytics. FDA recall Z-0518-2019. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-0518-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*