Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
VOCSN Patient Breathing Package (Pediatric Recalled by Ventec Life Systems, Inc. Due to The bonded spiral wrap may detach before or...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ventec Life Systems, Inc. directly.
Affected Products
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.
Quantity: 250 breathing circuits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 8 states: CA, CO, FL, HI, IN, MO, NC, WA
About Ventec Life Systems, Inc.
Ventec Life Systems, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report