Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 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: 32-005587

Recall Number: D-0160-2018

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

Classification: Class II

Status: Terminated

Report Date: 20180117

Initiation Date: 20170905

Termination Date: 20181219

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

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 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: 32-005587