FDAJune 26, 2020device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
precision valve automationprecisionprecision valve
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABD Kiestra" ReadA; Catalog No.: 446948.2026-02-06
- FDAJewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.2025-05-23
- FDAJewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.2025-05-22
- FDA1. Sqwincher Electrolyte Beverage Mix, orange powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025004; packaged in assorted case, 32 per case / 2.5 gal yield item number 159016044 2. Sqwincher Electrolyte Beverage Mix, grape powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025...2024-09-09
- FDASqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 1590164042024-09-09
- CPSCCrye Precision Recalls LRB™ Leg Loops Due to Fall Hazard (Recall Alert)2022-07-21
- CPSCTech Lighting Recalls Coda Pendant Light Fixtures Due to Impact Injury Hazard (Recall Alert)2022-06-23
- FDAThick-It Original Food & Beverage Thickener 6/36 oz. jars per case2022-06-09
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