Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1823-2024 — Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

U.S. FDA — Device Enforcement · New Zealand · 2024-04-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1823-2024
Date of alert
2024-04-02
Country / jurisdiction
New Zealand
Risk level
Class II
Risk type
recall
Brand
Fisher & Paykel Healthcare, Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
09420012422248
Reported risk: Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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