Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Summary
The FDA issued a Class II for Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US by Fisher & Paykel Healthcare, Ltd.. Reason: Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that m.
Details
Source
Device Recall
External ID
Z-1823-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Lot/Code Info: 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
Quantity Affected: 7,147
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-02
Company
Auckland, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fisher & Paykel Healthcare, Ltd. has 18 FDA actions in our database, including 3 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fisher & Paykel Healthcare, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fisher & Paykel Healthcare, Ltd. have FDA actions?
Fisher & Paykel Healthcare, Ltd. has 18 FDA actions in our database, including 3 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1823-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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