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Ventec Life Systems, Inc. recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used
Recalled March 6, 2024 · FDA recall Z-1070-2024 · Ventec Life Systems
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. · FDA Class I
Units
250 breathing circuits
Sold at
U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
Description
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.
Product
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.
Manufacturer(s)
Ventec Life Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →