Device product
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.
Z-2117-2014
Product summary
- Event
- Event 68681
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 208 cases; Foreign: 42 cases
- Official record key
device-enforcement:Z-2117-2014
Official wording
Reason: "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.
Code information: Lot Numbers 28619 & 28621
Distribution pattern: Worldwide Distribution -- USA, Canada, and Mexico.
Derived failure modes
-
Labeling or packaging
wrong labeling