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FDAFDA · Food and drugs·Recall number D-0160-2018

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

Published January 17, 2018 · Recall initiated: September 5, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Distributor
IA, WI
Lot
Lot: A257, EXP 05-20-2018; A258, EXP 05-19-2018; B017, EXP 01-12-2019; B116, B119, EXP 05-03-2019; B120, EXP 05-04-2019; B131, EXP 05-05-2019; Z535, EXP 10-13-2017; Z638, EXP 12-19-2017.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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