FDA-Device2014-08-06Class II
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
Dynarex Corporation
Hazard
"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
Sold states
Worldwide Distribution -- USA, Canada, and Mexico.
Affected count
Domestic: 208 cases; Foreign: 42 cases
Manufactured in
10 Glenshaw St, Orangeburg, NY, United States
Products
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2117-2014Don't want to check this manually?
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