# FDA recall Z-1371-2022

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2022-05-31.

## Product

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure  Part Number: 08-3301-2

## Reason for recall

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

## Distribution

Natiowide

## Key facts

- **Recall number:** Z-1371-2022
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-31
- **Report date:** 2022-07-20

- **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-1371-2022

## Citation

> AI Analytics. FDA recall Z-1371-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1371-2022. Source: US FDA. Licensed CC0.

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