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 Injection Recalled by ICU Medical Inc Due to CGMP Deviations

Date: February 4, 2019
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 Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09

Quantity: 475320 bags

Why Was This Recalled?

CGMP Deviations

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