# FDA recall D-0881-2018

> **ICU Medical Inc** · Class II · drug recall initiated 2018-05-31.

## Product

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37

## Reason for recall

Lack of assurance of sterility: Bags have potential to leak.

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** D-0881-2018
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-31
- **Report date:** 2018-06-27
- **Termination date:** 2020-06-04

- **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-0881-2018

## Citation

> AI Analytics. FDA recall D-0881-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0881-2018. Source: US FDA. Licensed CC0.

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