Olympus Corporation of the Americas recalls Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortn

Recalled February 9, 2022 · FDA recall Z-0551-2022 · Olympus Corporation of the Americas

Hazard

Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) · FDA Class II

Units

35 units

Sold at

US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.

Description

Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

Product

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00

Manufacturer(s)

Olympus Corporation of the Americas

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →