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 | Updates to the Instructions for Use. |
| Product | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has faile… |
| Quantity | 91731 total |
| Distribution | The products were distributed US Nationwide Distribution |
| Initiated | 2019-02-25 |
| Classified | 2019-03-19 |
| Terminated | 2020-09-29 |
| Recall number | Z-1024-2019 |
| 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-1024-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82226/
Alerts for COOK MEDICAL
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.