Recall of Cook Celect PlatinumVena Cava Filter Sets with specific catalog numbers and production dates from January 2019 to January 2022. The recall involves updates 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 certain PlatinumVena Cava Filter Sets due to updates to device descriptions, intended use, contraindications, warnings, precautions, and potential adverse events. This recall does not involve a safety hazard but requires users to check their product details against the listed catalog numbers and production dates.
The recall involves updates to the device's description, intended use, contraindications, warnings, precautions, and potential adverse events. These updates are part of standard medical device documentation and do not indicate a safety hazard or risk of injury.
Patients and medical professionals who own or use the specific Cook Celect PlatinumVena Cava Filter Sets with catalog numbers IGTCFS-65-1-FEM-CELECT-PT G34502, IGTCFS-65-1-JUG-CELECT-PT G34309, or IGTCFS-65-1-UNI-CELECT-PT G34505 manufactured between January 24, 2019 and January 24, 2022.
Check your Cook Celect PlatinumVena Cava Filter Set for the catalog numbers IGTCFS-65-1-FEM-CELECT-PT G34502, IGTCFS-65-1-JUG-CELECT-PT G34309, or IGTCFS-65-1-UNI-CELECT-PT G34505. These products were manufactured between January 24, 2019 and January 24, 2022.
Compare your product's catalog number and production date to the list of affected items provided in the recall notice.
No, this recall involves updates to device descriptions, intended use, contraindications, warnings, precautions, and potential adverse events. It does not indicate a safety hazard or risk of injury.
Check your product's catalog number and production date against the list of affected items in the recall notice. No action is required if your product is not on the list.
The affected products are Cook Celect PlatinumVena Cava Filter Sets with catalog numbers IGTCFS-65-1-FEM-CELECT-PT G34502, IGTCFS-65-1-JUG-CELECT-PT G34309, or IGTCFS-65-1-UNI-CELECT-PT G34505 manufactured between January 24, 2019 and January 24, 2022.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0876-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0876-2022 from Cook. 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.
