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U.S. Department of Health and Human Services

Class 2 Device Recall PVA, PREVENT

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 Class 2 Device Recall PVA, PREVENTsee related information
Date Initiated by FirmJune 26, 2020
Create DateAugust 14, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2805-2020
Recall Event ID 86082
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
ProductPVA, 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.
Code Information Lot #: EV123732 Serial #s: L1002, L1005, L1006
FEI Number 3001151872
Recalling Firm/
Manufacturer		 Precision Valve & Automation,Inc
1 Mustang Dr
Cohoes NY 12047-4856
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionCustomers will be e-mailed initial recall notice, followed by written letter. Customers will be directed to ship recalled PreVENT back to PVA as soon as possible. Recalled unit will be shipped back to PVA in the same packaging from replacement unit. Recalled units will be scrapped at PVA.
Quantity in Commerce3 units
DistributionWorldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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