FDA-Device2024-10-09Class I
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Percussionaire Corporation
Hazard
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Sold states
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Affected count
50,460 units
Manufactured in
130 Mcghee Rd Ste 109, N/A, Sandpoint, ID, United States
Products
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3207-2024Don't want to check this manually?
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