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 […]
Recalls
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, […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
BD recalls more Alaris pumps due to compatibility issues with Cardinal Health syringes
The FDA determined that another recall of BD (NYSE:BDX) Alaris infusion pumps is Class I, the most serious kind. In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices. […]
Baxter issues Novum IQ infusion pump warning
Correction: the original version of this article identified this as another recall for Novum IQ. Baxter issued a notification related to a Nov. 15 recall, not a notification for a separate recall. This story has been updated. Baxter (NYSE:BAX) issued an urgent medical device correction notice regarding its Novum IQ syringe infusion pump. A few […]
Eitan Medical’s Sapphire infusion pump recall is Class I
The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind. Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, […]
B. Braun infusion pump battery recall is Class I after one reported death
The FDA labeled a recall of B. Braun Medical infusion pump battery packs Class I, the most serious kind. B. Braun’s recall is a correction, not a product removal, affecting the battery pack for its Infusomat Space large-volume pump. It affects both wireless and non-wireless batteries, model numbers 8713051U and 8713052U. According to an FDA […]