Ventec Life Systems Recalls Ventilator Parts Due to Connector Disconnection Risk
Ventec Life Systems is recalling 100 units of ventilator parts because the internal flow transducer cable connector may disconnect, potentially interrupting ventilation therapy.
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: The recall is classified as FDA Class I because the internal flow transducer cable connector may disconnect, potentially interrupting ventilation therapy. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Ventec Life Systems, Inc. is recalling 100 units of VOCSN (Japan) Model Number PRT-01100-100, Package PN PRT-01126-100. These parts are used for ventilatory support. The recall covers all serial numbers with UDI 00850018761130.
The recall is being issued because the ventilator's internal flow transducer cable connector may disconnect from the internal board. This disconnection can potentially result in a system reboot and an interruption of ventilation therapy.
The affected units were distributed nationwide in the United States, including Puerto Rico. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The recalled product
- Product
- VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
- Manufacturer
- Ventec Life Systems, Inc.
- Affected units
- 100
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 (1)
- All Serial Numbers: UDI: 00850018761130
Distribution
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