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Swan-ganz double lumen monitoring catheter
Official notice
14 Jul 2023
Last checked
14 Jul 2023
An official Health Canada notice concerns Swan-ganz double lumen monitoring catheter. 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 Published 2023-07-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73956
Official notice
2023-07-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Affected area 1
Company & contacts
Company & contacts
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Manufacturer
Phone
Brand: Edwards Lifesciences, Swan-ganz Double Lumen Monitoring Catheter.
Source & status
Source & status
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Category
Classification
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Recall details
Recall details
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Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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