US FDA Deems MiniMed Safety Issues Class I Recall
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.
You may also be interested in...
Medtronic has announced a safety issue in its popular MiniMed 600 series of insulin pumps. The devices may under- or over-deliver insulin if a ring component of the device cracks or breaks, potentially causing serious health issues. The company says the issue doesn’t amount to a recall, however.
The hybrid closed-loop automated insulin delivery system, the first closed-loop system approved anywhere in the world, automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes.
The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.