| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00536-1 |
| Product Name/Description |
Neria Infusion Administration Set
Models : G27-6mm-60cm, G27-8mm-80cm, G27-10mm-80cm and Multi 2 G27-8mm
Ref. numbers: 78-060-2736, 78-080-2738, 78-080-2731 and 721060-2738
Lot numbers: 5017071, 5024517, 5033612, 227979, 227980, 5006113, 5006114, 5006115, 5028915, 5063419, 5020514, 5022947, 5033623, 5063787
ARTG number: 198459 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer of the product, Unomedical a/s has found that in rare cases the steel needle can break during use, interrupting the delivery of medication. If the needle breaks during use, the delivery of medicine will be interrupted and the patient may experience a range of symptoms depending on therapy area and medication used. Additionally, if a broken needle remains in the body, it can lead to infection which, in rare cases, might require surgical removal. |
| Recall Action |
Recall |
| Recall Action Instructions |
Clinect is notifying patients of the issue and providing instruction to ensure the safe use of the devices, however, should patients wish to return the device this can be arranged through their supplier. Clinect is also recovering potentially affected stock from hospitals, retailers and distributors. This action has been closed-out on 12/08/2016. |
| Contact Information |
1300 012 686 (Customer Service) |