Becker and Exacta External Drainage and Monitoring Systems — recall 76501
Health Canada — Medical Devices · Canada · 2024-11-14 · Type II
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Reported risk: Medtronic has received customer complaints reporting cracks and/or leaks on the stopcock of Becker and Exacta EDMS devices. On these devices, the stopcocks may be in three different locations in the EDMS, depending on the specific system configuration. Cracks or leaks of the stopcock can compromise line integrity and, as a result, present a potential for infection. Three adverse events associated with patient infection have been reported. Recall start date: November 1, 2024
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