VOCSN V+Pro Ventilator System Respiratory Device Safety Recall
Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a respiratory medical device. The hazard (oxygen leak with potential fire risk) could directly impact patient safety during critical ventilator support, meeting the Severe criteria for FDA Class I recalls involving risk of significant injury.
Plain-English summary
Ventec Life Systems, Inc. is recalling the VOCSN V+Pro ventilator package (REF: PRT-01198-000) and VOCSN V+Pro unit (REF: PRT-01185-000). The respiratory system is intended to provide continuous or intermittent ventilator support.
The devices may not have been fully evaluated under all intended high-pressure conditions during production testing. This could result in an oxygen leak condition that may lead to reduced oxygen delivery below intended levels prior to and during ventilation. An oxygen-enriched environment may increase fire risk.
A total of 42 units were distributed across Ohio, Georgia, California, and Missouri. Affected devices can be identified by specific serial numbers ranging from 152884 to 156532 (with some gaps in sequence).
Users with affected devices should contact Ventec Life Systems, Inc. immediately for guidance on safe operation or replacement of their equipment.
The recalled product
- Product
- VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
- Manufacturer
- Ventec Life Systems, Inc.
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914
- 152885
- 152886
- 152887
- 152888
- 152889
- 152890
- 152891
- 152892
- 152893
- 152895
- 152896
- 152897
- 152898
- 152899
- 152900
- 152901
- 152902
- 152903
- 152904
Distribution
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