# FDA recall D-0349-2020

> **ICU Medical Inc** · Class I · drug recall initiated 2019-10-25.

## Product

LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

## Reason for recall

Presence of Particulate Matter.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0349-2020
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-25
- **Report date:** 2019-11-13
- **Termination date:** 2022-01-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0349-2020

## Citation

> AI Analytics. FDA recall D-0349-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0349-2020. Source: US FDA. Licensed CC0.

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