The FDA determined that the recall of the Baxter (NYSE:BAX) Novum IQ syringe pump is Class 1, the most serious kind. Baxter designed its Novum IQ syringe pump as an infusion pump to deliver fluids into a patient’s body in a controlled manner. The device is suitable for patient care in hospitals and outpatient facilities […]
Recalls
FDA issues warning about over-the-counter eye drops
The FDA issued a notice warning consumers about 26 over-the-counter eye drop products that could result in eye infections. In its notice, the FDA instructed consumers not to purchase and to immediately stop using these products. Using those eye drops could lead to the risk of infections that could result in partial vision loss or […]
Medtronic warns on previous software MiniMed 780G in Germany
Medtronic (NYSE:MDT) issued an urgent field safety notice in Germany to warn of a potential issue with its MiniMed 780G system. MiniMed 780G, Medtronic’s next-generation automated insulin delivery system, has been available in Europe since earning CE mark in mid-2020. In March 2021, the company first communicated that its pumps with software version 6.5 could […]
Baxter warns on some infusion pumps due to potential false alarms
Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S. The FDA later issued a notice identifying the recall as Class I, the most serious kind. Baxter recalled 22,769 devices in total. Affected pumps in the U.S. and Puerto Rico received upgrades to software versions […]
B. Braun recalls some two-piece syringes due to potential packaging barrier damage
B. Braun issued an urgent field safety notice in Europe related to potential issues with certain two-piece syringes. The company’s notice said it decided to proactively recall a batch combination of the syringes. B. Braun identified a number of batches of its Exadoral, Henke-JECT, Norm-Ject and Injekt devices. In the course of postmarket surveillance and […]
ICU Medical recalls certain infusion pump replacement batteries
The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]
Medtronic Diabetes unit fully resolves FDA warning letter
Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of […]
Abbott FreeStyle Libre reader warning affects more than 4 million devices
The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind. Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from […]
Abbott warns on some FreeStyle Libre readers due to battery issues
Abbott (NYSE:ABT) initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The instructions cover the FreeStyle Libre, Libre 14-day and Libre 2 readers in the U.S. Abbott received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or […]
iRadimed issues urgent field safety notice for some infusion pump syringe adapters
iRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets. The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, […]