Z-2117-2014 Class II Terminated

Recalled by Dynarex Corporation — Orangeburg, NY

Recall Details

Product Type
Devices
Report Date
August 6, 2014
Initiation Date
July 2, 2014
Termination Date
April 20, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Domestic: 208 cases; Foreign: 42 cases

Product Description

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.

Reason for Recall

"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.

Distribution Pattern

Worldwide Distribution -- USA, Canada, and Mexico.

Code Information

Lot Numbers 28619 & 28621