| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00703-1 |
| Product Name/Description |
Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin)
Manufactured prior to May 2014
Multiple Lot Numbers – see attached list
ARTG Number: 116234 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a slight increase in reported cases of the steel needle breaking during use for infusions sets manufactured prior to May 2014. In a small sub set of these reported cases, this needle breakage has led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. Needle breakage can result in the interruption of insulin delivery and can cause hyperglycaemia, which if left untreated, can result in diabetic ketoacidosis (DKA). In addition to the interruption of insulin, a needle remaining in the body might, in rare cases, require surgical removal if the needle does not itself migrate to the surface where it can be removed with a pair of tweezers. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone AMSL for replacement with unaffected stock. This action has been closed-out on 15/08/2016. |
| Contact Information |
1300 851 056 - AMSL Diabetes Customer Service |