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Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier… recallZ-1823-2024 · Fisher & Paykel Healthcare, Ltd. · initiated Apr 2, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fisher & Paykel Healthcare, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 4/2/24, recall notices were sent to biomedical and respiratory department customers informing them to do the following: 1) Quarantine affected devices and work with firm to arrange collection and replacement. 2) Should a patient need to continue to use the device, the patient is instructed to contact their physician. Distributors are asked to facilitate device collection and replacement for their customers: a) If affected product has been further distributed create a list of affected customers for tracking purposes. b) Use the firm provided templates to create recall letters and response forms. Send the recall notice and response form to your customers to whom your firm has distributed affected devices. c) This recall notice should be shared with anyone who needs to be aware both within your organization and forwarded to any organization/ where potentially affected devices have been transferred. 3) Complete and return the response form via email at [email protected] Firm is removing and replacing affected devices. If you have any questions, please contact firm Customer Care via email at [email protected] or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.

Recall details

Recall number
Z-1823-2024
Status
Open, Classified
Initiated by the company
Apr 2, 2024
Posted by the FDA
May 15, 2024
Recalling firm
Fisher & Paykel Healthcare, Ltd.
Quantity
7,147
Product code
BTT
FDA submissions
K131895
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.

Product description

Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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