FDA-Device2023-05-24Class I

Seattle PAP Plus, MP02260

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
32,050 untis
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Seattle PAP Plus, MP02260

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1439-2023

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