Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex C…

Recall date

September 5, 2017

Source

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

Recall number

D-0159-2018

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), 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