FDA-Device2024-03-06Class I
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
Ventec Life Systems, Inc.
Hazard
The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.
Sold states
U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
Affected count
250 breathing circuits
Manufactured in
22002 26th Ave Se, Bothell, WA, United States
Products
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1070-2024Don't want to check this manually?
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