Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit
Reason for Recall / Hazard
Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin.
Product Description & Identification
Reason / Defects: Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin. Hazards: If insulin is under-delivered, this may lead to adverse health events including severe hyperglycaemia or the user may experience diabetic ketoacidosis (DKA) and may require hospitalisation or intervention from a medical professional. What to do: Consumers should check whether they have an affected product and if so stop using them. Consumers should contact Roche Diabetes Customer Care to make arrangements to receive a replacement. For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01541-1 For further information, please contact Roche Diabetes Customer Care by phone on 1800 251 516.
Affected Products
Accu-Chek Solo Cannula Assembly & Pump Holder (9 mm; 10+3 & 6 mm; 10+3) and Accu-Chek Solo Supply Kit (9 mm) & (6 mm) Cannula lot numbers: 847468303 and lower Reference numbers: 07858833001, 07858841001, 07858817001 & 07858825001 ARTG 308704 (Roche Diabetes Care Australia Pty Ltd - Insulin infusion patch pump administration set) ARTG 311432 (Roche Diabetes Care Australia Pty Ltd - Ambulatory insulin infusion administration set/reservoir kit)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 8a0612cf-cfec-42f3-a4a1-339f2a0cab38 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/accu-chek-solo-cannula-assembly-pump-holder-and-accu-chek-solo-supply-kit |
| Pub Date | Fri, 23 Dec 2022 00:00:00 +0000 |