Swan-Ganz Double Lumen Monitoring Catheter
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Swan-Ganz Double Lumen Monitoring Catheter |
All lots. |
110F5 |
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
Additional information
Details
Edwards Lifesciences LLC
1 Edwards Way, Irvine, California, United States, 92614
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