# FDA recall D-0216-2019

> **ICU Medical Inc** · Class II · drug recall initiated 2018-10-08.

## Product

0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045

## Reason for recall

Lack of Assurance of Sterility; bags have the potential to leak

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0216-2019
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-10-08
- **Report date:** 2018-11-14
- **Termination date:** 2021-03-08

- **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-0216-2019

## Citation

> AI Analytics. FDA recall D-0216-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0216-2019. Source: US FDA. Licensed CC0.

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