Dexcom (Nasdaq:DXCM) has issued an update related to a recall for its continuous glucose monitor (CGM) components. Last month, the FDA disclosed Dexcom’s recalls related to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature the established G6 and G7 sensors […]
Recalls
BD issues voluntary recall on certain Alaris infusion pump modules
BD (NYSE:BDX) announced a voluntary recall related to certain Alaris and Alaris infusion pump modules. Affected Alaris products may have been serviced with previously recalled bezel kit assemblies. BD in 2019 recalled those kit assemblies manufactured between April 2011 and June 2017. They should not be used for service with the Alaris and Alaris Pump […]
Zyno recalls certain infusion pumps due to software issue
The FDA classified a recall of certain Zyno Medical infusion pump systems as the most serious kind as a result of a software issue. This recall involves removing certain devices from use or sale. As the most serious type of recall, it means the device may cause serious injury or death if its use continues. […]
Dexcom has a Class I CGM receiver recall
The FDA’s recall database today posted notices related to a Class I recall for continuous glucose monitor (CGM) components made by Dexcom (Nasdaq:DXCM). Dexcom’s recalls relate to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature […]
Baxter issues serious correction for large-volume infusion pump
The FDA has warned of a serious potential issue with Novum IQ large-volume infusion pumps made by Baxter (NYSE:BAX). Baxter’s recall of the system involves updating instructions for use. It does not require removal from use or sale. However, the FDA identified it as the most serious type of recall, carrying the risk of injury […]
Smiths Medical warns on trio of infusion pump issues
The FDA issued three notices identifying warnings sent out by ICU Medical‘s Smiths Medical unit related to infusion pump problems. Smiths Medical warned of issues with some of its CADD-Solis and CADD-Solis VIP ambulatory infusion pumps. The CADD-Solis pump offers utility in hospital or outpatient settings, delivering pain therapies. CADD-Solis VIP pumps are intended for […]
Baxter warns on certain infusion pumps with missing screws
The FDA today issued a notice warning of a potential high-risk issue with certain Baxter (NYSE:BAX) Spectrum infusion pump systems. This communication came as part of the FDA’s pilot to enhance its medical device recall program. It follows a letter from Baxter recommending that customers remove certain Spectrum pumps from where they are used or sold. […]
Medtronic warns on air pressure issue with certain MiniMed insulin pumps in Europe
Medtronic (NYSE:MDT) issued an urgent field safety notice in Europe related to multiple versions of its MiniMed insulin pump systems. The medtech giant’s notice includes models of the MiniMed 640G, 670G, 720G, 740G, 770G and 780G insulin pumps. During quality testing performed by Medtronic, the company said it recently found that changes in air pressure […]
Dexcom warns of missed G6 receiver alerts in Europe
Dexcom (Nasdaq:DXCM) recently issued an urgent field safety notice in Europe warning of a potential issue with certain G6 receivers. G6 continuous glucose monitor (CGM) receivers deliver glucose readings and alerts. However, certain devices may experience an issue in which alarms/alerts fail to function as designed. In rare instances, the alarm/alert may be missed or […]
Cardinal Health recalls certain insulin syringe component packs
The FDA deemed a recall of Cardinal Health (NYSE:CAH) insulin syringe luer lock packs as type I, the most serious kind of recall. This recall relates to the company’s Monoject U-100 mL insulin syringe luer lock with tip cap soft pack (extended conical tip). The device is used to administer insulin under the skin (subcutaneous) or […]
