PVA, PREVENT is an FDA-authorized emergency ventilator recall
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device…
Why was PVA, PREVENT is an FDA-authorized emergency ventilator recalled?
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: EV123732 Serial #s: L1002, L1005, L1006
- Product
- PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device…
- Recalling firm
- Precision Valve & Automation,Inc
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
- Recall date
- August 26, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)