# FDA recall D-0517-2020

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2019-11-19.

## Product

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only,  Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29

## Reason for recall

Lack of  Assurance of Sterility: Product has the potential to leak.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0517-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-19
- **Report date:** 2019-11-27
- **Termination date:** 2021-02-04

- **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-0517-2020

## Citation

> AI Analytics. FDA recall D-0517-2020. Retrieved 2026-06-21 from https://api.ai-analytics.org/recall/D-0517-2020. Source: US FDA. Licensed CC0.

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