The Therapeutic Goods Administration (TGA) and Roche Diabetes Care have issued an urgent medical device recall for Accu-Chek Solo cannula assembly and pump holder, and the supply kit.

Roche Diabetes Care has identified that insulin leakage has occurred in a small number of cases with the Accu-Chek Solo cannula assembly and pump holder (6mm and 9mm, NDSS codes 851 and 852) and the Accu-Chek Solo supply kit (6mm and 9mm).

Discontinue use of these products immediately.

The insulin leakage may not be noticed straight away, which could lead to an under-delivery of insulin.

The possible consequences could range from no clinical impact to severe hypoglycaemia (dangerously low blood glucose levels) or diabetic ketoacidosis (DKA).

Please contact Roche Diabetes customer care on 1800 251 816 for information on how to return the impacted stock and receive the replacement.

The complete recall notice from the TGA is available here.