Recall of Cook Celect Platinum Vena Cava Filter Sets for Femoral Vein Approach due to updates to Instructions for Use. Product catalog numbers listed.
Updates to the Instructions for Use.
Cook Medical is recalling certain vena cava filter sets used in femoral vein procedures because their instructions for use have been updated. This recall does not involve a safety hazard but requires users to check if they have the affected product.
The recall is due to updates to the Instructions for Use, which means users need to follow the new guidance. There is no indication of a physical hazard or injury risk from the product itself.
Patients and medical professionals who have the specific Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach with the listed catalog numbers. The risk is minimal as the update is to instructions, not a safety issue.
Check if your product has the catalog number IGTCFS-65-1-FEM-CELECT-PT. The product is used for preventing pulmonary embolism in specific medical situations involving the femoral vein.
Look for the catalog number IGTCFS-65-1-FEM-CELECT-PT on the product packaging or label.
The recall is due to updates to the Instructions for Use, which require users to follow the new guidance for safe use.
No, the recall does not involve a safety hazard. The update is to instructions for use, not a physical defect.
No, the recall does not require stopping use. You only need to check if you have the affected product and follow the updated instructions.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1024-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-1024-2019 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.
