Recall StatusTerminated
Date Initiated2020-10-30
Date Terminated2024-12-31
Product Quantity384,767 units
Reason for Recall
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
Firm Action
Invacare issued Urgent Notification letter on 10/30/20 to providers and consumers via email stating reason for recall, health risk and action to take:
Visit www.Invacare.com/RC928 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of affected device serial numbers sold to you and instructions to conduct this field correction. You will be prompted to provide responses to information requested regarding this field correction and affected units.
2. Review your existing stock to locate the affected devices.
3. Review the Repair Instructions provided on the www.Invacare.com/RC928 website.
4. Order field correction service kits and conduct field correction repair activities on affected devices during their next regularly scheduled maintenance service. Details on how to order the service kits are provided on the website www.Invacare.com/RC928.
5. Field correction repairs must be completed on affected units before October 30, 2021. If you currently use a service provider for maintenance and repair, they can execute this field action service.
6. You are responsible for ensuring that this field correction is conducted with your customers. Customers who own affected units should be contacted and informed about this field correction. We recommend that you provide them with the Consumer Letter provided on the www.Invacare.com/RC928 website.
Invacare provided copies of the US and Canada notification letters to Invacare Europe for their reference and distribution.
Distribution Pattern
Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.