Reported Dec 14, 2022 · Ongoing
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Getinge USA Sales Inc.
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: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035
Is this the product you have?
- Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
- Lot codes and dates
- Flow-c UDI-DI7325710010457 Lot/Serial Numbers
40034777478350245025502650275028504350445045504650475048504950505078
- Flow-e UDI-DI7325710009765 Lot/Serial Numbers
50012500135001450015500165001750030500315003350034500355003650037500385003950040500415004250043500465004750048500515005250053500545005550056500575005850059500605006150062500695007050071500725007350074500845008550086500875008850089500905009150092500935009450096500975010850109501105011150132
- Flow-c UDI-DI7325710010457 Lot/Serial Numbers
- Amount recalled
- 65 US
Where it was sold
Why it was recalled
The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
This product could cause temporary or reversible health problems — stop using it.
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