Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

0.9% SODIUM CHLORIDE Irrigation Recalled by ICU Medical Inc Due to Presence of particulate matter.one confirmed customer report of...

Date: March 9, 2021
Company: ICU Medical Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical Inc directly.

Affected Products

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

Quantity: 425,628 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ICU Medical Inc

ICU Medical Inc has 50 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report