# FDA recall D-0062-2023

> **ICU Medical Inc** · Class II · drug recall initiated 2022-11-09.

## Product

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

## Reason for recall

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0062-2023
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-11-09
- **Report date:** 2022-11-23

- **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-0062-2023

## Citation

> AI Analytics. FDA recall D-0062-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0062-2023. Source: US FDA. Licensed CC0.

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