FDA Warns ICU Medical Over Infusion Pump Modifications
The FDA has issued a warning letter to ICU Medical, citing regulatory violations related to unapproved modifications to two of its infusion pumps.
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FDA Clears ICU Medical’s New Plum Solo and Duo Infusion Pumps
With the clearances, ICU Medical introduces its new category of infusion devices, designed to address infusion delivery variability.
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BD Issues Correction for Infusion Pump Software
BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.
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FDA Issues Early Alert on Baxter Spectrum Infusion Pump Recall
The FDA has issued an early alert regarding Baxter’s recall of certain Spectrum infusion pumps due to missing motor mounting screws, which may have occurred during servicing.
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OptumHealth Recalls Nimbus II Plus Infusion Pumps
OptumHealth Care Solutions is recalling Nimbus II Plus infusion pumps due to multiple failure modes, following an InfuTronix recall.
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