Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The stated reason is documentation updates.
Plain-English summary
Cook Medical Incorporated is recalling the Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach. The recall is being conducted to provide updates to the Instructions for Use for the product.
The affected product is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava. A total of 9,173 units were distributed nationwide. The recall covers specific lot numbers listed in the official FDA record.
Healthcare providers and patients should consult the updated Instructions for Use provided by Cook Medical. 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
- Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cav
- 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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