Product Wiki · Recalls · Health Canada — Medical Devices

Solex 7 Intravascular Heat Exchange Catheter Kit — recall 63524

Health Canada — Medical Devices · Canada · 2021-10-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63524
Date of alert
2021-10-29
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: This labeling correction involves revising the catheter IFU to include warning/caution statements about potential health risks due to overloading of the Sterile Saline fluid. This recall only affects the IFU; not the Catheters. Initial recall date: 2021-09-30
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/solex-7-intravascular-heat-exc

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