Recall record at a glance
| Official record | Z-2805-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Precision Valve & Automation, Inc. |
| Report date | Aug 26, 2020 |
| Recall initiation date | Jun 26, 2020 |
| Quantity | 3 units |
| Location | Cohoes, NY, United States |
Official product description
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.
Why the product was 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.
Distribution information
Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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