# FDA recall Z-1311-2022

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2022-06-01.

## Product

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

## Reason for recall

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

## Distribution

US Nationwide distribution in the states of Texas and Louisiana.

## Key facts

- **Recall number:** Z-1311-2022
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-13
- **Termination date:** 2024-10-07

- **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-1311-2022

## Citation

> AI Analytics. FDA recall Z-1311-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1311-2022. Source: US FDA. Licensed CC0.

---

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