# FDA recall D-0542-2023

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2023-03-15.

## Product

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

## Reason for recall

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0542-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-03-15
- **Report date:** 2023-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2023

## Citation

> AI Analytics. FDA recall D-0542-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0542-2023. Source: US FDA. Licensed CC0.

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