| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00444-1 |
| Product Name/Description |
Mylife YpsoPump Orbit micro 2.0 infusion sets
mylife YpsoPump Orbit micro
Cannula: 5.5 mm, steel
Tubing: 45 cm (18”)
Reference number: MYOYP2-1851
mylife YpsoPump Orbit micro 2.0
Cannula: 5.5 mm, steel
Tubing: 60 cm (24”)
Reference number: MYOYP2-2451
ARTG 281787
(Ypsomed Australia Pty Ltd - Electric infusion pump administration set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
mylife YpsoPump Orbit micro 2.0 (steel cannula), introduced in 2023, has a different adhesive patch and minor differences in design compared to mylife YpsoPump Orbit micro (steel cannula), introduced in June 2016. While benefit of these changes have been seen in most patients, a small number are experiencing different degrees of skin irritation ranging from mild to severe. The risk associated with this problem is acute allergic or irritant contact dermatitis causing skin irritation that may result in symptoms such as itching, burning, and/or rash at the site of adhesive patch application. This pattern was first recognised in November 2023. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers are to alert patients who may be using the device to the potential for skin reactions and encourage users to discuss their individual situation and needs with their healthcare professional, who may recommend aids to minimise or avoid irritations, as well as possible infusion set alternatives compatible with the mylife YpsoPump insulin pump.
Ypsomed is monitoring the situation in the field, investigating the causes of the skin reactions and is exploring possible measures to mitigate this problem. When a mitigation is identified, this will be communicated with customers. |
| Contact Information |
1800 447 042 - Customer Care hotline |