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15 Results Found
Recall issued for aspiration system by Q’Apel Medical
The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.
FDA issues alerts on certain catheters produced by BD, Conavi
The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi.
FDA recalls Medtronic Aortic Root Cannulas
The Food and Drug Administration has identified a Class I recall of Medtronic Aortic Root Cannulas due to a risk of unexpected loose material in the male luer used in the cannula.
Recall issued for Becton, Dickinson and Company infusion pump adapters
The Food and Drug Administration has identified a Class I recall of Becton, Dickinson and Company BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapters due to reports that customers using Systems Manager software who are also connected to the system’s CCE Infusion Adapter may experience delayed system response and backlogging of automated programming requests.
FDA issues recall on Medtronic embolization devices
The Food and Drug Administration has identified a Class I recall of Medtronic Neurovascular 027 Compatible Pipeline Vantage Embolization Devices due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures.
Baxter recalls Spectrum infusion pumps
The Food and Drug Administration March 5 announced that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws.
ICU Medical recalls certain lots of potassium chloride injection bags due to mislabeling
The Food and Drug Administration Feb.
White House announces tariffs on steel and aluminum imports
The Trump administration yesterday announced it issued
Baxter alerts providers to potential high-risk issues with devices
The Food and Drug Administration Dec. 31 released an alert highlighting a Baxter letter that recommended health care providers not use certain lots of Solution Sets with Duo-Vent Spikes due to a potentially high-risk issue.
FDA announces firm distributing Chinese-made plastic syringes in the U.S. initiates recall
Medline Industries initiates recall of Chinese-made plastic syringes in the U.S.