Agency classClass IOur severity:Critical FDA (Devices)·Z-1070-2024·Announced 2024-03-06

VOCSN Pediatric breathing package spiral wrap detachment risk during ventilation

Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device classification combined with a confirmed manufacturing defect affecting a life-critical respiratory device. The hazard is not theoretical—spiral wrap detachment is occurring—and poses explicit risk of serious injury or death, particularly in ventilator-dependent patients.

Plain-English summary

Ventec Life Systems, Inc. is recalling 250 units of the VOCSN Patient Breathing Package (Pediatric, Active, Oxygen) with reference numbers PRT-01013-000 (package) and PRT-00802-001 (pouch). The product is used with the VOCSN Unified Respiratory System to provide continuous or intermittent ventilatory support for patients requiring mechanical ventilation.

The bonded spiral wrap in the breathing circuit may detach before or during ventilation due to a manufacturing issue. Detachment can compromise the structural integrity, functionality, and performance of the device, resulting in occlusions (blockages) or leaks in the breathing circuit.

This defect creates a serious risk of injury or death, particularly for ventilator-dependent patients who rely on continuous respiratory support. The affected products were distributed in the United States to facilities in California, Colorado, Florida, Hawaii, Indiana, Missouri, North Carolina, and Washington, as well as to Japan. Affected units have lot number 220922 or pack slip lot number 257337.

Patients and healthcare providers should immediately cease use of affected units and contact Ventec Life Systems for instructions on replacement or repair.

The recalled product

Product: 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…
Manufacturer: Ventec Life Systems, Inc.
Category: Medical Device — Respiratory Support
Hazard: detachment
obstruction
leak
malfunction
Affected units: 250

Distribution

Distributed in 8 states:

Same manufacturer · Ventec Life Systems, Inc.

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Same hazard · detachment