FDAFDA · Food and drugs·Recall number Z-2117-2014
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.
Published August 6, 2014 · Recall initiated: July 2, 2014
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
"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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dynarex Corporation
- Distributor
- Worldwide Distribution -- USA, Canada, and Mexico.
- Lot
- Lot Numbers 28619 & 28621
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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