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FDA issues most serious recall for certain ventilators
The Food and Drug Administration has identified a Class I recall of Philips Respironics V30, A30 and A40 ventilators due to the potential for serious injury or death.
FDA issues most serious recall for Edwards Lifesciences cannulas
The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for serious injury or death.
Recall issued by FDA for certain craniotomy kits
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy Kits containing recalled Codman Disposable Perforators 14mm due to the potential of serious injury or death.
FDA recalls two products for potential of serious harm
The Food and Drug Administration July 21 identified Class I recalls of two products due to the potential for serious injury of death.
FDA announces recall of cefazolin by Sandoz for mislabeling
The Food and Drug Administration July 15
FDA issues recall on tubes used to manage bleeding
The Food and Drug Administration has identified a
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.
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.