Cook Medical is recalling Tulip Vena Cava Filter Sets for Femoral Vein Approach (catalog numbers IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, IGTCFS-65-1-UNI-TULIP) manufactured from January 24, 2019 through January 24, 2022. This recall includes an update to device descriptions, intended use, contraindications, warnings, precautions, and potential adverse events.
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Cook Medical is recalling Tulip Vena Cava Filter Sets for Femoral Vein Approach (catalog numbers IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, IGTCFS-65-1-UNI-TULIP) manufactured between January 24, 2019 and January 24, 2022. The recall involves an update to the device description, intended use, contraindications, warnings, precautions, and potential adverse events. This update is not a safety hazard but a correction to documentation.
The recall involves an update to the device description, intended use, contraindications, warnings, precautions, and potential adverse events. This is a documentation update to clarify how the device should be used and what risks to be aware of, not a safety hazard that could cause injury.
Patients who received these specific Tulip Vena Cava Filter Sets for Femoral Vein Approach (catalog numbers IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, IGTCFS-65-1-UNI-TULIP) manufactured between January 24, 2019 and January 24, 2022 are affected. Healthcare providers using these devices are also impacted.
Check for the catalog numbers IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, or IGTCFS-65-1-UNI-TULIP on the product packaging. The devices were manufactured between January 24, 2019 and January 24, 2022.
Check the product packaging for the catalog numbers IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, or IGTCFS-65-1-UNI-TULIP to confirm if your device is affected.
No, this recall involves an update to the device description, intended use, contraindications, warnings, precautions, and potential adverse events. It is not a safety hazard but a correction to documentation.
No action is required. This recall is for documentation updates only, not a safety issue.
The affected catalog numbers are IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, and IGTCFS-65-1-UNI-TULIP.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0875-2022 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0875-2022 from Cook Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
