FDAClass INovember 7, 2012

Adult Resuscitator recall

Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide…

Why was Adult Resuscitator recalled?

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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?

Product List 071012, Product Code: PRO-5009P, Lot #102217.

Product
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide…
Recalling firm
Ventlab Corporation
Quantity
14,602 total for all units
Distribution
Nationwide Distribution including IL, OH, NY and TN.
Recall date
November 7, 2012
Classification
Class I
Status
Terminated
Agency
FDA (device)
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