B. Braun Medical, Inc. is recalling the Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms that may lead to interruptions in the delivery of high-risk medications, potentially causing serious harm or death, with 51 complaints, one injury, and one death reported.
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ICU Medical Inc. announces that it has received U.S. Food and Drug Administration 510(k) regulatory clearance for the Plum Duo infusion pump with LifeShield infusion safety software. The products will be available in early 2024.
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Baxter announced an urgent issue with its Spectrum V8 and Spectrum IQ infusion pumps related to recent software updates.
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Supernus Pharmaceuticals plans to resubmit its application seeking approval of SPN-830, its apomorphine infusion pump for people with Parkinson’s disease, to the FDA by the end of this year.
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IRadimed Corp. issued an Urgent Medical Device Correction Letter regarding a potential issue with some 1057 Syringe Adapter Sets.
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