Product Wiki · Recalls · Health Canada — Medical Devices

Gunther Tulip Vena Cava Filter Set, Cook Celect Platinum Vena Cava… — recall 59055

Health Canada — Medical Devices · Canada · 2019-03-15 · Type III

As described by Health Canada — Medical Devices: Gunther Tulip Vena Cava Filter Set, Cook Celect Platinum Vena Cava Filter Set (2019-03-04)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
59055
Date of alert
2019-03-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A Field Safety Notice is being launched to ensure affected customers are aware of the new version of the Inferior Vena Cava (IVC) Filter IFUs. The changes impact the device labels and the following sections of the IFUs: Device Description, Intended Use, Contraindications, Warnings, Precautions, MRI Safety Information, Potential Adverse Events, Clinical Studies, step-by-step Instructions for Use, and References.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/gunther-tulip-vena-cava-filter

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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