Reported Nov 19, 2014 · Terminated
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Drive · Wayne, NJ · 07470
Is this the product you have?
- Cardiohelp-I System Product UsageA blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours)
- Lot codes and dates
331 of 331 codes
904108039041098490410456904106099041061090410740904107379041073890410733904108659041100590410552904105729041084990410864904108679041079690410481904103199041032890411176904109889041070390410431904111869041118890411191904108009041061190410669904105179041069290410499904105009041073990410612904107149041075990410771904104309041027690410576904104829041074990410774904108599041086090410863904110889041108290411087904110919041108990410866904111449041097090411023904110339041103890411032
- Amount recalled
- 331 units
Where it was sold
- Nationwide
Why it was recalled
Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
This product could cause temporary or reversible health problems — stop using it.
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