Reported Mar 6, 2024 · Ongoing
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used…
Ventec Life Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventec Life Systems, Inc. · 22002 26th Ave Se · Bothell, WA · 98021-4903
Is this the product you have?
- 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.
- Lot codes and dates
- Box Label - Part NumbersPRT-01013-000
- Pouch Label - Part NumberPRT-00802-001
- UDI-DI Code00855573007594
- Lot Number220922
- Pack Slip Lot Number257337
- Amount recalled
- 250 breathing circuits
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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