FDAClass IIJanuary 17, 2018

Sterile Eyewash recall: Sterility Concern

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a.…

Why was Sterile Eyewash recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: Z516

Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a.…
Recalling firm
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Quantity
29,232 1 oz bottle
Distribution
IA, WI
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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