FDA-Drug2018-01-17Class II

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 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: 32-005583

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

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

Sold states
IA, WI
Affected count
22,080 4 oz bottles
Manufactured in
330 Corporate Woods Pkwy, N/A, Vernon Hills, IL, United States
Products
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 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: 32-005583

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0158-2018

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