# FDA recall D-0351-2019

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2019-01-02.

## Product

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL  60015; Product Code 5B9766, NDC 0941-0424-52.

## Reason for recall

Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

## Distribution

Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.

## Key facts

- **Recall number:** D-0351-2019
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-02
- **Report date:** 2019-01-16
- **Termination date:** 2020-04-29

- **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-0351-2019

## Citation

> AI Analytics. FDA recall D-0351-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0351-2019. Source: US FDA. Licensed CC0.

---

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