Class 2 Device Recall AIRVO 2 Humidifier, myAirvo 2 Humidifier

• Date Initiated by Firm: April 02, 2024
• Date Posted: May 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1823-2024
• Recall Event ID: 94398
• 510(K)Number: K131895
• Product Classification: Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
• Product: Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
• Code Information: 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
• Recalling Firm/ Manufacturer: Fisher & Paykel Healthcare, Ltd.; 15 Maurice Paykel Place; East Tamaki; Auckland New Zealand
• For Additional Information Contact: 649574-0100
• Manufacturer Reason for Recall: 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 Determined Cause: Nonconforming Material/Component
• Action: 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 FieldAction.USA@fphcare.com Firm is removing and replacing affected devices. If you have any questions, please contact firm Customer Care via email at FieldAction.USA@fphcare.com or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BTT