FDAJanuary 9, 2024device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
ventec life systemsventecventec life
UPCs
00855573007594
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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