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Recall Observatory FDA recall evidence

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

July 02, 2014

Class II

Product summary

Firm
Dynarex Corporation
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

    reason.labeling_packaging · v1.0.0

    wrong labeling