Tag: Correction

29
Nov

UDI Examples of Medical Devices Under a Voluntary Device Correction

UDI Examples – Compliant or Non-Compliant? CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrillation Electrodes. The labels of which are examples of UDI implementation by the CONMED Corporation. View more UDI labels of these products here. Compliance Issue The following UDI example is based on the GS1 system of standards.  As for the date format, UDI labels

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28
Jun

FDA | Medical Device Class I Recalls | SynchroMed Implantable Infusion System Devices

By Regulatory Doctor LinkedIn Google Plus Twitter Facebook Tumblr FDA | Medical Device Class I Recalls | SynchroMed Implantable Infusion System Devices Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls – Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion AUDIENCE: Patients, Healthcare Professionals, Risk Managers ISSUE: In June 2013, Medtronic, Inc. initiated four medical device notifications to customers worldwide about the SynchroMed

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