FDA DeviceClass INotable
FDA Recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Produc
Description
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Hazard
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Remedy
550 (367 US; 183 OUS)
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