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.

Sterile Eyewash (sterile isotonic phosphate buffered saline solution) Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Due to Lack of sterility assurance: leaking containers which could...

Date: September 5, 2017
Company: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
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 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company directly.

Affected Products

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585

Quantity: 130,740 16 oz bottles

Why Was This Recalled?

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Where Was This Sold?

This product was distributed to 2 states: IA, WI

Affected (2 states)Not affected

About Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company has 18 total recalls tracked by RecallDetector.

Related Recalls

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