Ventec VC+Pro Ventilators Recalled for Potential Cable Disconnection
Ventec Life Systems is recalling VC+Pro ventilators because an internal cable may disconnect, causing system reboots and interruption of 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 Class I because the internal cable disconnection may interrupt ventilation therapy, posing a risk of serious adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Ventec Life Systems, Inc. is recalling 1,534 units of the VC+Pro ventilator (Model Number: PRT-00900-001, Package PN: PRT-00973-000). The device is used for ventilatory support. The recall is classified as Class I by the U.S. Food and Drug Administration.
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.
Healthcare providers and consumers should stop using the affected ventilators immediately and contact Ventec Life Systems for instructions on repair or replacement. The affected units are identified by the UDI codes 00855573007785 and 00855573007433.
The recalled product
- Product
- VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
- Manufacturer
- Ventec Life Systems, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 1,534
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 (2)
- All Serial Numbers: UDI: 00855573007785
- 00855573007433
Distribution
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