FDA Drug Moderate Class II Terminated

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

Reported: January 17, 2018 Initiated: September 5, 2017 #D-0159-2018

Product Description

Reason for Recall

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

Details

Recalling Firm: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Units Affected: 130,740 16 oz bottles
Distribution: IA, WI
Location: Vernon Hills, IL

Frequently Asked Questions

What product 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. Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company. Units affected: 130,740 16 oz bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0159-2018.