Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Tag: class 1 recall
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Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
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Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Infusion System Replacement Batteries Get FDA Class I Recall
These infusion system replacement batteries were recalled because a defect has diminished how long they can be used to run the system, which may cause the system to shut down an ongoing infusion.
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Fresenius Kabi Recalls Ivenix Infusion System
Fresenius Kabi has issued a voluntary recall of the Ivenix Infusion System due to a leak in the system that allows fluid to enter the administration set loading area near the air detector.
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Avanos Medical Recalls Closed Suction Systems for Young Children
The FDA has identified Avanos Medical’s recall of certain airway access devices for children, infants, and neonates as a Class I recall
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Getinge Subsidiary’s Intra-Aortic Balloon Pumps Get Class I Recall
Getinge subsidiary Datascope is recalling two types of Intra-Aortic Balloon Pumps due to the possibility of unexpected device shutdown.
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FDA Class I Recalls Hit 15-Year High in 2022
Sedgwick released its 2023 Product Recall Index, which detailed why defective and violative products reached a record-breaking high.
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Reworked Philips Ventilators Get Class I Recall for Potential Foam Debris Issues
Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.
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GE HealthCare Recalls Nuclear Medicine Systems
GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two of its mechanisms.
