Reported May 6, 2020 · Ongoing
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Radiometer Medical ApS
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: Radiometer Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
- ABL800 FLEX model number 393-800 and 393-801
- UDI(01)05700693938004
- Lot codes and dates
- Serial Numbers902-754R2692N002 and 902-754R2692N001
- Amount recalled
- 2 units
Where it was sold
Why it was recalled
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
This product could cause temporary or reversible health problems — stop using it.
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