Reported Mar 31, 2021 · Terminated

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake…

ICU Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835

Is this the product you have?

  • 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
Lot codes and dates
  • Lots
    • 16-808-4B
    • 16-803-4B
    • 16-809-4B
    • Exp. April 01
    • 2023
Amount recalled
425,628 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new ICU Medical Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 28, 2022 · Data as of Sep 19, 7:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.