Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ 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 (Device)

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

Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿

Quantity: 9,828

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 nationwide across all 50 states.

Affected (51 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 (Device). Last updated March 26, 2026. View original report