Recall Z-1823-2024 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Fisher & Paykel Healthcare, Ltd.
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
| Date | May 15, 2024 (initiated Apr 2, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 f |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER Fisher & Paykel Healthcare, Ltd., Oct 24, 2013 |