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FDA Issues Class I Recalls of Datex-Ohmeda Infant Warmers Over Oxygen Delivery Defect

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By People's Justice

What happened

The FDA announced two Class I recalls of Datex-Ohmeda infant radiant warmers — including the Panda Freestanding Warmer and the Giraffe and Panda Warmers with Integrated Resuscitation Systems — after finding that a blender knob shaft can loosen and cause the device to deliver an oxygen concentration that does not match the level set by the user. According to the FDA enforcement records, this malfunction could result in hypoxia or hyperoxia in the patient. Class I is the FDA's most serious recall classification, reserved for situations where use of the device may cause serious injury or death.

Event date:

Source: api.fda.gov

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