The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Reason for recall: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. Distribution: US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America. Quantity: 9 Lot/code info: UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E
00606959429338
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.