FDAFDA · Food and drugs·Recall number Z-1070-2024
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.
Published March 6, 2024 · Recall initiated: January 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventec Life Systems, Inc.
- Distributor
- U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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