Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN:… — Class III medical device recall Z-0876-2022
Terminated recall by Cook Medical Incorporated, reported 2022-04-13, distributed nationwide. IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications,
| Recall number | Z-0876-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2022-02-14 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-11-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, CA, CL |
| Quantity | 52,590 units |
| UPC / GTIN / UDI-DI | 01082700234502, 10827002343099, 10827002345024, 10827002345055 |
| Model numbers | G34502, IGTCFS-65-1-FEM-CELECT-PT |
Product
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
Reason for recall
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0876-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.