Ventec Life Systems Recalls VOCSN Ventilator Parts Due to Cable Disconnection
Ventec Life Systems is recalling 1,532 VOCSN ventilator parts because an internal 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 cable disconnection may interrupt ventilation therapy, posing a reasonable probability of serious adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Ventec Life Systems, Inc. is recalling 1,532 units of VOCSN Model Number PRT-01100-000 (Package PN: PRT-01126-000). These parts are used for ventilatory support and were distributed nationwide in the United States, including Puerto Rico. The affected units are identified by UDI 00855573007747.
The recall is being conducted 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 source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare facilities should contact Ventec Life Systems, Inc. for instructions on how to address the affected units.
The recalled product
- Product
- VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
- Manufacturer
- Ventec Life Systems, Inc.
- Affected units
- 1,532
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: 00855573007747
Distribution
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