Medtronic—Angiographic Guidewire Components: Sterility May Be Compromised [FDA Class I]

June 23, 2021 | Strategic Insights for Health System


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Problem: ​FDA's Center for Devices and Radiological Health (CDRH) states that the above products were intended for shipment to a third party to be further processed into kits and sterilized; however, they were instead shipped directly to customers. FDA's CDRH also states that the manufacturer initiated a...

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