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Health Canada Medical devices

Swan-Ganz Double Lumen Monitoring Catheter

Issued July 14, 2023
Issue
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
Hazard description
Labelling and packaging
Product
Product name
Swan-Ganz Double Lumen Monitoring Catheter
Reference
ID
RA-73956