Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex C…

Recall date

September 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0157-2018

FDA classification

Class II

Brand / firm

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

Sold / distributed

IA, WI

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 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: 32-005582.