FDAClass INovember 7, 2012

Stat-Check Resuscitator recall

Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by…

Why was Stat-Check 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 Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193.

Product
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by…
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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