ICU Medical’s Smiths Medical unit issued an urgent field safety notice in Europe to warn of issues with certain medication cassette reservoirs. Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and […]
Recalls
ICU Medical recalls some infusion pump batteries, updates instructions
The FDA issued a notice to warn of a recall of ICU Medical (Nasdaq:ICUI) Plum 360 infusion pump system batteries due to a manufacturing defect. ICU Medical designed its Plum 360, Plum A+ and Plum A+3 systems for large-volume fluid infusion. The system delivers blood or blood products, drugs and other fluid mixtures through subcutaneous, […]
Tandem Diabetes Care begins updated software rollout after recall
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it released version 2.8.2 of its Apple iOS t:connect mobile app in the U.S. The company initiated the new software release to remedy issues with prior versions of the technology. Its t:connect mobile app works in conjunction with the t:slim X2 automated insulin pump with Control-IQ technology. Tandem […]
Abbott recalls some FreeStyle Libre 3 sensors in U.S.
Abbott (NYSE:ABT) announced today that it initiated a voluntary recall for a small number of FreeStyle Libre 3 continuous glucose monitor (CGM) sensors. The company distributed the affected sensors during the first half of May 2024. Abbott did not disclose the number of sensors affected but said the recall affects a small subset of FreeStyle […]
Merit Medical recalls certain products containing syringes made in China
Merit Medical issued an urgent medical device recall notice related to specific products that contain plastic syringes made in China. Certain lots of Merit products contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Merit received notice from its supplier indicating that it supplied the company with those syringes. All but one size/type of […]
Medline plastic syringe recall expands
The FDA says Medline initiated additional recalls as the company grapples with issues surrounding syringes made in China. Medline’s latest recalls aim to stop using affected products that include bulk unauthorized plastic syringes made in China and bulk plastic syringes made in China with performance testing failures. These add to last month’s recalls asking customers […]
Recall of Tandem Diabetes Care insulin pump app software is Class I, more than 200 injuries reported
The FDA labeled a recall of a Tandem Diabetes Care (Nasdaq:TNDM) automated insulin delivery app’s software Class I, the most serious kind. This recall constitutes a correction, not a product removal. Tandem recalled Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 pump with Control-IQ technology. It initiated […]
Medtronic warns on MiniMed 780G battery caps in Europe
Medtronic (NYSE:MDT) issued an urgent field safety notice in Europe to warn of battery cap compatibility issues with the MiniMed 780G. MiniMed 780G offers automated insulin delivery to those with type 1 diabetes. It features SmartGuard technology to eliminate the need for fingersticks. Its Meal Detection Technology provides automatic adjustments and corrections to sugar levels […]
BD warns on some neXus V700 infusion pumps outside the U.S.
BD [WtwhTicker symbol=”BDX”](NYSE: BDX)[/WtwhTicker] issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system. According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The […]
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
