PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 17, 2018 Initiated: September 5, 2017 #D-0157-2018

Product Description

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.

Reason for Recall

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

Details

Units Affected
29,232 1 oz bottle
Distribution
IA, WI
Location
Vernon Hills, IL

Frequently Asked Questions

What product 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.. Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company. Units affected: 29,232 1 oz bottle.
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-0157-2018.