Percussionaire Corporation recalls Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Val…

Recall date

August 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3208-2024

FDA classification

Class I

Brand / firm

Percussionaire Corporation

Sold / distributed

US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey

Why it was recalled

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve