Class III — Cook Medical Incorporated
| Recalling firm | COOK MEDICAL |
|---|---|
| Registered facility | COOK MEDICAL LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events |
| Product | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918 |
| Quantity | 24,641 units |
| Distribution | US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam |
| Initiated | 2022-02-14 |
| Classified | 2022-04-06 |
| Terminated | 2024-11-07 |
| Recall number | Z-0875-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Cook Medical Incorporated (Z-0875-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89689/
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