Class I Recall For Cook Medical Guide Wire
The US FDA gave its highest risk designation to Cook’s recall of its Fixed Core Wire Guide.
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Consensus report CR511 from the Association for the Advancement of Medical Instrumentation highlights common system elements for engineers, and outlines safety and risk-control measures that manufacturers and caregivers should consider.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.