Unomedical, which supplies diabetes tech firms including Medtronic, Tandem Diabetes Care and Beta Bionics, received more than 5,000 complaints about leaking infusion sets between 2023 and 2025.
ConvaTec is a leading global manufacturer of widely popular infusion sets offering a variety of patient choice Beta Bionics is developer of the iLet Bionic Pancreas System and is committed to device ...
The Food and Drug Administration has categorized Unomedical’s recall of VariSoft infusion sets as a Class I event. Unomedical, working with its partner Tandem Diabetes Care, contacted customers last ...
The tubing used to subcutaneously deliver insulin from a Tandem Diabetes Care pump is among the latest devices to land in the FDA’s hot seat. Unomedical A/S began a recall of some of its VariSoft ...
Unomedical A/S, a maker of single-use medical devices, is pulling about 130,000 insulin infusion products from the market because it might detach mid-infusion, according to the FDA. Nearly 130,700 ...
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