CLASS II Device recall · Reported 6 Aug 2014 · FDA Enforcement Report

CPR Shield With One Way Valve and Barrier Filter recalled by Dynarex

Dynarex is recalling CPR Shield With One Way Valve and Barrier Filter. The recall was initiated on 2 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers 28619 & 28621

Quantity recalledDomestic: 208 cases; Foreign: 42 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2117-2014
FDA event ID: 68681
Recalling firm: Dynarex, Orangeburg, NY
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2014
FDA classified: 25 Jul 2014
Reported: 6 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

2 Jul 2014	Recall initiated by company
25 Jul 2014	Classified by FDA	+23 days
6 Aug 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution -- USA, Canada, and Mexico.

Questions about this recall

Is CPR Shield With One Way Valve and Barrier Filter recalled?

Yes. Dynarex recalled CPR Shield With One Way Valve and Barrier Filter on 2 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2117-2014.

Why was it 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.

Which lots are affected?

Lot Numbers 28619 & 28621

Where was it sold?

Worldwide Distribution -- USA, Canada, and Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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