| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00041-1 |
| Product Name/Description |
Trustcare Outdoor Rollators
Manufacturing dates 2016-2021
ARTG 163591
(HMR Healthcare Pty Ltd - Walking aid, two arms, frame, wheeled) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/02/2022 |
| Responsible Entity |
|
| Reason/Issue |
HMR lifecare has become aware about the breakage of the backrest of outdoor rollators during multiple instances.
The health risk associated with this issue is a potential misuse of the product and maintenance not being carried out.
The current version of IFU does not contain any warning to ensure correct use and maintenance of the product.
Two incidents of customer injuries have been reported to date associated with the impacted product. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
HMR are advising customers to inspect the stock on hand immediately which have been purchased between 2016-2021 to prevent further use until the new IFU will be supplied (will be provided to only impacted customers by the sponsor).
HMR are advising retailers to advise all the existing end users about the updates who have already purchased the products between 2016-2021.
HMR are indicating that an updated version of IFU is outlined with the correct use and maintenance of the product and will be provided in the due course. |
| Contact Information |
07 5477 0777 - HMR Healthcare |