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. The products were distributed nationwide.
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, which by definition is unlikely to cause adverse health consequences, and the stated reason is a documentation update (Instructions for Use) rather than a physical defect or contamination.
Plain-English summary
Cook Medical Incorporated is recalling 9,173 units of the Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach (Catalog Number IGTCFS-65-1-JUG-TULIP). The recall was initiated to update the Instructions for Use for these medical devices.
The affected products were distributed nationwide in the United States. The recall covers specific lot numbers, including E3401429, E3401430, and E3402143, among others. The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava.
Healthcare providers and patients should contact Cook Medical Incorporated for further instructions regarding the updated documentation. This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP 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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