# FDA recall D-0313-2021

> **ICU Medical Inc** · Class II · drug recall initiated 2021-03-09.

## Product

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

## Reason for recall

Presence of particulate matter.one confirmed  customer report of particulate matter within two semi-rigid bottles identified prior to use

## Distribution

Distributed Nationwide in the USA to include Puerto Rico

## Key facts

- **Recall number:** D-0313-2021
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-09
- **Report date:** 2021-03-31
- **Termination date:** 2022-09-28

- **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-0313-2021

## Citation

> AI Analytics. FDA recall D-0313-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0313-2021. Source: US FDA. Licensed CC0.

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