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October 5, 2021October 5, 2021 – Medtronic is expanding a 2019 recall of its MiniMedTM 600 Series Insulin Pumps to include any MiniMed 600 series pump that has a clear retainer ring. The U.S. FDA considers this a Class I recall, as use of the affected devices could cause serious injury or death due to incorrect insulin dosing.
- There is no impact to members through Benecard Central Fill.
- Insulin pumps are used to deliver insulin for the treatment of diabetes in individuals who are at least 16 years old. The affected pumps may have a missing or broken clear retainer ring, which is needed to properly lock the insulin cartridge into the pump's reservoir compartment. A faulty or missing ring could lead to over or under delivery of insulin. This can cause potentially deadly low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia).
- Medtronic is aware of serious injuries and deaths occurring with the use of MiniMed 600 series insulin pumps, though the company states that these may not have been directly related to the damaged or missing retainer rings.
- Medtronic has provided instructions for consumers in possession of MiniMed 600 series pumps through the recall notice, which can be found on the U.S. FDA's website. Consumers should examine their pump according to these instructions. Questions or requests for additional information can be directed to Medtronic Technical Support at 1-877-585-0166.