FDAClass IIAugust 6, 2014

CPR Shield With One Way Valve and Barrier Filter recall: Labeling Error

CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in…

Why was CPR Shield With One Way Valve and Barrier Filter recalled?

"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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers 28619 & 28621

Product
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in…
Recalling firm
Dynarex Corporation
Quantity
Domestic: 208 cases; Foreign: 42 cases
Distribution
Worldwide Distribution -- USA, Canada, and Mexico.
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls