FDA-Device2023-05-24Class I

Set2Go Ventilation 12 (A), MP07968

Draeger Medical, Inc.
Hazard

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Sold states
Domestic: US Nationwide Distribution.
Affected count
500 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Set2Go Ventilation 12 (A), MP07968

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2023

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