Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Produc
Pending LLM rewrite. Source: FDA_DEVICE Z-2357-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance
- Manufacturer
- Datex-Ohmeda Inc
- Category
- Medical Device — Devices
Distribution
Distribution scope not specified by the agency.
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