| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00941-1 |
| Product Name/Description |
ResMed Masks with Magnets
AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her, AirTouch N20, AirTouch N20 for Her, AirFit F20, AirFit F20 for Her, AirTouch F20, AirTouch F20 for Her, AirFit F30, AirFit F30i.
All lot numbers
ARTG's 300769 & 300768
(Resmed Limited - CPAP/BiPAP face mask reusable) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
ResMed is updating existing contraindications and warnings of ResMed Masks with magnets which can potentially affect the functioning of certain implanted medical devices such as pacemakers, implantable cardioverter defibrillators, neurostimulators, cerebrospinal fluid shunts, insulin/infusion pumps and metallic implants/objects containing ferromagnetic material (aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye).
Keep the mask magnets at a safe distance of at least 6 inches (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference.
Under certain circumstances when a magnet is in close proximity to certain medical implants/devices, potential magnetic interference may affect the performance or implanted position of the implant/device which has the potential to lead to serious injury or death.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
ResMed is updating its existing contraindications and warnings as outlined in the customer letter (supplied to impacted customers only by ResMed).
If patients, or anyone in close physical contact with the patient while using the mask (e.g. bed partner), have a medical implant identified within the customer letter they are to:
- Contact their mask provider to replace their mask with magnets with an alternative mask without magnets.
- Keep the mask magnets at a safe distance of 6 inches (150 mm) away from implants/medical devices. This applies to patients and anyone in close physical contact with the mask magnets.
- If an alternative mask is not available consult their physician immediately to determine if another mask can be used.
- Dispose of the mask with magnets after you receive an alternative mask.
If customers are not contraindicated from using a ResMed mask with magnets the mask can continue to be used following the updated instructions in the customer letter. |
| Contact Information |
1300 305 705 - ResMed Pty Ltd |