Public recall detail

Swan-Ganz Double Lumen Monitoring Catheter

2023-07-14

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Recall Safety notice
Quick summary

Quick summary: Swan-Ganz Double Lumen Monitoring Catheter. Date: 2023-07-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Swan-Ganz Double Lumen Monitoring Catheter. Date: 2023-07-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEdwards Lifesciences LLC
ProductSwan-Ganz Double Lumen Monitoring Catheter
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-73956

Affected products

ProductSwan-Ganz Double Lumen Monitoring Catheter
LotAll lots.
Model110F5
Serial numberAll lots.
DescriptionSwan-Ganz Double Lumen Monitoring Catheter

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California, United States, 92614
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73956
Background{}
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California, United States, 92614
AudiencesHealthcare
Source updated2023-07-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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