Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and is initiated solely to update the Instructions for Use, which aligns with the rubric for documentation issues and cosmetic defects.
Plain-English summary
Cook Medical Incorporated is recalling 9,173 units of the Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach. The recall is being conducted to provide updates to the Instructions for Use for the device.
The affected products are identified by Catalog Number IGTCFS-65-1-FEM-TULIP and specific lot numbers listed in the agency record. The products were distributed nationwide in the United States.
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava. Consumers and healthcare providers should refer to the updated Instructions for Use provided by the manufacturer.
The recalled product
- Product
- Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:
- Manufacturer
- Cook Medical Incorporated
- Hazard
- Affected units
- 91,731
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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