Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Reported: April 13, 2022 Initiated: February 14, 2022 #Z-0875-2022
Product Description
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Reason for Recall
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Details
- Recalling Firm
- Cook Medical Incorporated
- Units Affected
- 24,641 units
- Distribution
- US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918. Recalled by Cook Medical Incorporated. Units affected: 24,641 units.
Why was this product recalled? ▼
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Low. Recall number: Z-0875-2022.
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