Tag: Product Recalls
First step taken in FDA-issued unique device identification system
Medical device manufacturers have taken the first step in complying with the 7-year unique device identification (UDI) process mandated by the Food and Drug Administration (FDA). The UDI system establishes a consistent way to label and track medical devices from production to use, and is intended to improve patient safety…
Stryker's Neptune recall raises stakes for compliance
Strict requirements needed to comply with a recall for the Neptune brand of roving suction devices are raising questions and concern for ORs whose facilities continue to use the devices. The recall of the Neptune Waste Management System from Stryker, used to collect and dispose of fluid waste, was initiated…
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