CLASS I ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
Vocsn Patient Breathing Package (Pediatric, Active, Oxygen, Blue) recalled
Ventec Life Systems is recalling Vocsn Patient Breathing Package (Pediatric, Active, Oxygen, Blue), distributed in 8 states. The recall was initiated on 9 Jan 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1070-2024
- FDA event ID
- 93806
- Recalling firm
- Ventec Life Systems, Bothell, WA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Jan 2024
- FDA classified
- 23 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- CPAP & Ventilators
Timeline
| 9 Jan 2024 | Recall initiated by company | |
| 23 Feb 2024 | Classified by FDA | +45 days |
| 6 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
CaliforniaColoradoFloridaHawaiiIndianaMissouriNorth CarolinaWashington
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ventec Life Systems
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vocsn+Pro package recalled by Ventec Life Systems | Ventec Life Systems | Device Malfunction | Nationwide |
| Device | CLASS I | Vocsn V+Pro package recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | 4 states |
| Device | CLASS I | Vocsn Multi-Function Ventilators: Vocsn+Pro (V+O+C+S+N+Pro, English) recalled | Ventec Life Systems | Labeling Errors | CA, MO, NY |
| Device | CLASS II | Vocsn Multi-Function Ventilator recalled by Ventec Life Systems | Ventec Life Systems | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |