Published: 26 October, 2023 TGA Reference: RC-2023-RN-00909-1 ARTG: 116234 Australasian Medical & Scientific Ltd (AMSL) has found that in rare cases the VariSoft infusion set connector detaches more easily from the infusion set than expected, requiring less force to disconnect than intended, and thereby interrupting the delivery of insulin. The NDSS products affected by this recall are: · NDSS Code 832 – Tandem VariSoft Infusion Set t:lock (13mm, 60cm) · NDSS Code 833 – Tandem VariSoft Infusion Set t:lock (17mm, 60cm) This has impacted VariSoft Infusion Sets with the following lot and item numbers: Lot Number Item Number 5388357 1002827 5388368 1002830 5388372 1002827 AMSL advises consumers, healthcare professionals and distributors to examine your stock immediately to determine if you have any of the product lots referenced above on hand. If so, discontinue using these immediately. Please complete and return the form here via email to [email protected] for the recall process. You will be receiving replacement products that do not have an increased risk of connector detachment and can therefore safely be used. Further information from AMSL can be found here. Please contact AMSL by emailing [email protected] or calling 1300 851 056 for further information.
