Precision Valve & Automation,Inc: Medical Device Recall in 2020 - (Recall #: Z-2805-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 26, 2020

Date Posted: August 26, 2020

Recall Number: Z-2805-2020

Event ID: 86082

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.

Status: Ongoing

Product Quantity: 3 units

Code Information:

Lot #: EV123732 Serial #s: L1002, L1005, L1006

Distribution Pattern:

Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.

Voluntary or Mandated:

Voluntary: Firm initiated