Airvo 2 Humidifier recall
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Why was Airvo 2 Humidifier recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI: PT100US/09420012422248, PT101US 09420012422347. Serial Number Range: 120521XXXXXX - 170813XXXXXX Note: X digits are variable and do not affect the identification of the affected range. Devices manufactured before 14 August 2017
- Product
- Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Quantity
- 7,147
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Recall date
- May 22, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)