Gunther Tulip Vena Cava Filter Set, Cook Celect Platinum Vena Cava Filter Set (2019-03-04)

Starting date:

March 4, 2019

Posting date:

March 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69306

• Reason
• Affected products

Affected Products

1. Gunther Tulip Vena Cava Filter Set
2. Cook Celect Platinum Vena Cava Filter Set

Reason

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.

Affected products

A. Gunther Tulip Vena Cava Filter Set

Lot or serial number

All lots.

Model or catalog number

• IGTCFS-65-1-FEM-TULIP
• IGTCFS-65-1-JUG-TULIP
• IGTCFS-65-1-UNI-TULIP

Companies

Manufacturer

William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK




B. Cook Celect Platinum Vena Cava Filter Set

Lot or serial number

All lots.

Model or catalog number

• IGTCFS-65-1-FEM-CELECT-PT
• IGTCFS-65-1-JUG-CELECT-PT
• IGTCFS-65-1-UNI-CELECT-PT

Companies

Manufacturer

William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK