Recall Management
Managing recalls and safety alerts related to medical devices is more than another administrative task; it is a critical patient safety function. Setting in place an effective hazards and recall system can reduce a significant source of risk before patient harm occurs.
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.
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…
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…
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.
The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes.