Product Wiki · Recalls · Health Canada — Medical Devices

Swan-Ganz Double Lumen Monitoring Catheter — recall 73956

Health Canada — Medical Devices · Canada · 2023-07-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73956
Date of alert
2023-07-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: The Swan-Ganz catheter model 110F5 contain stainless steel bushings and are inappropriately labeled as MR safe. As per ASTM F2503, "MR safe" items include non-conducting, non-metallic, non-magnetic items. A complaint was reported in United Kingdom, when scanning a patient in MRI, artifacts were noticed around the catheter tip. There was no patient harm. no incident was reported in Canada. Recall start date: July 4, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/swan-ganz-double-lumen-monitor

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