Recall Z-1823-2024

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 taken

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.