Reported Apr 3, 2019 · Terminated
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to…
Maquet Cardiovascular US Sales, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Cardiohelp Emergency Drive, Part No. 70104.8002
- Product UsageThe Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails
- Lot codes and dates
- Affected serial numbers
90420359904212049042118890421279904212289042176190420904904202319042045590421304
- Affected serial numbers
- Amount recalled
- 10
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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