FDA Device recall Z-0875-2022
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917
- FDA Device
- Class III
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class III recall of Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917 by Cook Medical, citing IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0875-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-02-14 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook Medical |
| Distribution | US |
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
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Identifiers
| code_info | All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration Dates from January 8, 2022 through January 18…All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration Dates from January 8, 2022 through January 18 2025. RPN GPN LOT UDI IGTCFS-65-1-UNI-TULIP G52918 E3814493 1082700252918920220114E3814493 IGTCFS-65-1-UNI-TULIP G52918 E3817291 1082700252918920220123E3817291 IGTCFS-65-1-UNI-TULIP G52918 E3817898 1082700252918920220125E3817898 IGTCFS-65-1-UNI-TULIP G52918 E3818494 1082700252918920220128E3818494 IGTCFS-65-1-FEM-TULIP G52917 E3813763 1082700252917220220110E3813763 IGTCFS-65-1-FEM-TULIP G52917 E3815476 1082700252917220220116E3815476 IGTCFS-65-1-FEM-TULIP G52917 E3815477 1082700252917220220116E3815477 IGTCFS-65-1-FEM-TULIP G52917 E3817125 1082700252917220220123E3817125 IGTCFS-65-1-FEM-TULIP G52917 E3817562 1082700252917220220124E3817562 IGTCFS-65-1-FEM-TULIP G52917 E3818360 1082700252917220220128E3818360 IGTCFS-65-1-FEM-TULIP G52917 E3818361 1082700252917220220128E3818361 IGTCFS-65-1-FEM-TULIP G52917 E3819474 1082700252917220220131E3819474 IGTCFS-65-1-JUG- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0875-2022%22
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