FDA-Device2023-05-24Class I

VentStar Basic (N) 180, MP00353

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
1,725 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
VentStar Basic (N) 180, MP00353

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2023

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