Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]
Recalls
Medtronic facing class action suit from Canada MiniMed insulin pump users
A national class action in Canada has been commenced against Medtronic (NYSE:MDT) over its MiniMed 630G and 670G insulin pumps. Rochon Genova and Cardill Law commenced the proposed class action suit against Medtronic, Medtronic MiniMed and Medtronic of Canada over the insulin pumps approved for use in the country in 2016 and 2018. The pumps […]
BREAKING: Medtronic expands Class I recall of MiniMed 600 series insulin pumps
The FDA today announced that Medtronic (NYSE:MDT) has expanded the Class I recall of its MiniMed 600 series insulin pumps. Medtronic today notified customers by email and phone that the recall has been expanded to replace all MiniMed 600 series insulin pumps that contain the clear container ring. The Fridley, Minnesota-based company first warned of […]
Baxter working on software upgrade for serious Spectrum IQ problems
Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps. Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to […]
Cardinal Health recalls some saline syringes due to air embolism risk
Cardinal Health (NYSE:CAH) has initiated a U.S. recall of its Monoject Flush prefilled saline syringes due to an issue with the reintroduction of air. Dublin, Ohio-based Cardinal Health on Aug. 4 recalled approximately 267 million Monoject Flush devices because they have been found to reintroduce air into the syringe after the air has been expelled, […]
Baxter has a serious recall involving infusion pump software
The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program. Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into […]
Teva initiates U.S. recall of Topotecan metastatic ovarian cancer injection treatment
Teva Pharmaceuticals (NYSE:TEVA) initiated a voluntary recall of a lot of its Topotecan injection 4mg/4mL (1mg/mL) in the U.S. The voluntary recall came as a result of a complaint received from a pharmacy after a single glass particle was observed inside one vial. Following further examination of the complaint sample, two other particulates were found […]
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
BD applicators cited in medical kit recall
A medical care kit company is recalling more than 8,200 kits because they contain BD applicators that may become contaminated with a fungus. The recall by Medical Action Industries covers certain of its 306 Medical Convenience Kits, distributed between December 12, 2019, and March 22, 2021, according to the FDA. The agency has labeled the […]
BD’s Alaris pump hit with another serious recall
A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]
