Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog… — Class III medical device recall Z-0875-2022
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-0875-2022 |
|---|---|
| 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 | 24,641 units |
| UPC / GTIN / UDI-DI | 10827002529165, 10827002529172, 10827002529189 |
| Lot numbers | 0325E3967450, 1082700252916520220115E3814878, 1082700252916520220122E3815833, 1082700252916520220122E3815866, 1082700252916520220124E3817486, 1082700252916520220124E3817561, 1082700252916520220129E3818790, 1082700252916520220201E3819879, 1082700252916520220201E3819880, 1082700252916520220204E3820105, 1082700252916520220206E3820736, 1082700252916520220206E3820824, 1082700252916520220207E3821141, 1082700252916520220211E3821812, 1082700252916520220212E3822124, 1082700252916520220213E3822544, 1082700252916520220215E3823251, 1082700252916520220225E3825280, 1082700252916520220226E3825903, 1082700252916520220226E3825939, 1082700252916520220227E3826432, 1082700252916520220228E3826939, 1082700252916520220304E3827747, 1082700252916520220314E3831778, 1082700252916520220315E3832304, 1082700252916520220319E3833437, 1082700252916520220319E3833505, 1082700252916520220319E3833536, 1082700252916520220320E3834015, 1082700252916520220325E3835562, 1082700252916520220326E3836157, 1082700252916520220327E3836517, 1082700252916520220329E3837955, 1082700252916520220329E3838006, 1082700252916520220401E3838383, 1082700252916520220402E3838874, 1082700252916520220405E3840814, 1082700252916520220409E3841694, 1082700252916520220409E3841695, 1082700252916520220410E3842192 and 460 more |
| Model numbers | G52917, IGTCFS-65-1-FEM-TULIP |
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
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-0875-2022. 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.