Cook Medical recalls Tulip Vena Cava Filter Sets for Femoral Vein Approach with catalog numbers IGTCFS-65-1-FEM-TU LIP due to updated instructions for use. Affected units include specific lots listed in the recall notice.
Updates to the Instructions for Use.
Cook Medical is recalling Tulip Vena Cava Filter Sets for Femoral Vein Approach with catalog number IGTCFS-65-1-FEM-TU LIP. The recall is due to updates to the Instructions for Use, which may affect safe medical application.
The recall is due to updates to the Instructions for Use. These updates may impact how the device is safely applied in medical procedures to prevent pulmonary embolism.
Medical professionals who use this device for preventing pulmonary embolism may be affected. Patients receiving this device as part of their treatment could also be impacted.
Check for the catalog number IGTCFS-65-1-FEM-TU LIP on the product packaging. The affected units include specific lots listed in the recall notice.
Identify the catalog number and lot numbers listed in the recall notice to determine if your device is affected.
The recall is due to updates to the Instructions for Use, which may affect safe medical application.
Check the catalog number and lot numbers listed in the recall notice to determine if your device is affected.
The recall does not specify a hazard that could cause injury; it is due to updated instructions for 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-1021-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-1021-2019 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.
