device · product 1 of 1
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.
- Recall number
- Z-1070-2024
- Initiated
- January 09, 2024
- Classification
- Class I
- Status
- Ongoing
- Recalling firm
- Ventec Life Systems, Inc.
- Quantity
- 250 breathing circuits
App-derived interpretation
Unknown
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.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
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.
Code information
Box Label - Part Numbers: PRT-01013-000 Pouch Label - Part Number: PRT-00802-001 UDI-DI Code: 00855573007594 Lot Number: 220922 Pack Slip Lot Number: 257337
Distribution pattern
U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan