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 […]
Recalls
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 […]
Fresenius Kabi has a Class I recall of Ivenix Infusion System software
The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind. Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or […]
Smiths Medical warns on some infusion pumps
An urgent field safety notice issued in Europe warns of software issues with some CADD-Solis ambulatory infusion pumps made by Smiths Medical. The ICU Medical unit corrected some issues in previous software updates but some problems persist. For starters, according to the communication, the infusion pump may not alarm for an upstream occlusion. This issue […]
InfuTronix has a Class I infusion pump recall
InfuTronix recently announced a voluntary recall of the Nimbus ambulatory infusion pump system from the U.S. market. Following the voluntary removal, the FDA deemed the recall Class I, the most serious kind. It affects 52,328 devices in the U.S. in total. The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, […]
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
ICU Medical’s Smiths Medical has a major syringe pump recall
The FDA this week said it’s designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency’s most serious level of medical device recall. The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, […]
