FDAClass IApril 3, 2019

Cardiohelp Emergency Drive recall

Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable…

Why was Cardiohelp Emergency Drive recalled?

Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.

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?

Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304

Product
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable…
Recalling firm
Maquet Cardiovascular Us Sales, Llc
Quantity
10
Distribution
US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Recall date
April 3, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls