Cook Medical recalls certain vena cava filter sets for femoral and jugular vein approaches due to updated instructions for use. This recall does not involve a safety hazard but requires users to review the latest instructions to ensure proper application.
Updates to the Instructions for Use.
Cook Medical is recalling specific vena cava filter sets for femoral and jugular vein approaches. The recall is due to updated instructions for use, which means users must follow the latest guidelines to ensure safe placement and removal of the filter.
The hazard is an update to the Instructions for Use, which means the product's application and removal procedures have been revised. This update is necessary to ensure safe and effective use of the filter but does not pose a direct safety risk if the current instructions are followed.
Patients who have received the Cook Celect Platinum Vena Cava Filter Set for femoral and jugular vein approaches with the listed lot numbers are affected. Medical professionals using this product for procedures are also at risk if they have not updated their practices.
Check the product label for the catalog number IGTCFS-65-1-UNl-C and the lot numbers listed in the recall notice. The product is intended for use in specific medical procedures to prevent pulmonary embolism.
Check the product's label for the catalog number IGTCFS-65-1-UNl-C and lot numbers to confirm if it is affected. Review the latest Instructions for Use provided by Cook Medical.
No, the recall is due to updated instructions for use, not a safety hazard. The product is safe if used according to the latest guidelines.
No, the recall does not require stopping use. However, you must follow the updated instructions for proper application and removal.
Review the updated Instructions for Use from Cook Medical. If you have the product with the listed catalog number and lot numbers, ensure you follow the latest guidelines for safe use.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1026-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-1026-2019 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.
