Cook Celect Platinum Vena Cava Filter Set Instructions Recall
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall based on an update to the device instructions for use. No illnesses or injuries have been reported. The recall involves clarification of labeling information and falls within the documentation issues category of the severity rubric.
Plain-English summary
Cook Medical Incorporated is recalling Cook Celect Platinum Vena Cava Filter Sets. The recall affects three catalog numbers: IGTCFS-65-1-FEM-CELECT-PT (G34502), IGTCFS-65-1-JUG-CELECT-PT (G34309), and IGTCFS-65-1-UNI-CELECT-PT (G34505). Affected units were manufactured between January 24, 2019 and January 24, 2022, with expiration dates ranging from January 8, 2022 to January 18, 2025. A total of 52,590 units are affected.
The recall is issued to update the instructions for use (IFU) for the affected devices. The IFU update includes revisions to the device description, indications for use, contraindications, warnings, precautions, and information regarding potential adverse events.
Affected products were distributed nationwide in the United States and internationally to Canada, the Bahamas, Chile, and Guam.
The recalled product
- Product
- Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
- Manufacturer
- Cook Medical Incorporated
- Hazard
- labeling-deficiency
Distribution
Distributed nationwide across the United States.
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