Recall archive / FDA device enforcement
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS... — FDA record Z-0875-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 14, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class III
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 24,641 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0875-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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-TULIP G52916 E3814878 1082700252916520220115E3814878 IGTCFS-65-1-JUG-TULIP G52916 E3815833 1082700252916520220122E3815833 IGTCFS-65-1-JUG-TULIP G52916 E3815866 1082700252916520220122E3815866 IGTCFS-65-1-JUG-TULIP G52916 E3817486 1082700252916520220124E3817486 IGTCFS-65-1-JUG-TULIP G52916 E3817561 1082700252916520220124E3817561 IGTCFS-65-1-JUG-TULIP G52916 E3818790 1082700252916520220129E3818790 IGTCFS-65-1-UNI-TULIP G52918 E3820413 1082700252918920220205E3820413 IGTCFS-65-1-UNI-TULIP G52918 E3821142 1082700252918920220207E3821142 IGTCFS-65-1-UNI-TULIP G52918 E3821784 1082700252918920220211E3821784 IGTCFS-65-1-UNI-TULIP G52918 E3822904 1082700252918920220214E3822904 IGTCFS-65-1-UNI-TULIP G52918 E3825281 1082700252918920220226E3825281 IGTCFS-65-1-UNI-TULIP G52918 E3826948 1082700252918920220228E3826948 IGTCFS-65-1-FEM-TULIP G52917 E3820061 1082700252917220220204E3820061 IGTCFS-65-1-FEM-TULIP G52917 E3820252 1082700252917220220204E3820252 IGTCFS-65-1-FEM-TULIP G52917 E3821156 1082700252917220220207E3821156 IGTCFS-65-1-FEM-TULIP G52917 E3821463 1082700252917220220208E3821463 IGTCFS-65-1-FEM-TULIP G52917 E3821811 1082700252917220220211E3821811 IGTCFS-65-1-FEM-TULIP G52917 E3822125 1082700252917220220212E3822125 IGTCFS-65-1-FEM-TULIP G52917 E3822898 1082700252917220220214E3822898 IGTCFS-65-1-FEM-TULIP G52917 E3825267 1082700252917220220225E3825267 IGTCFS-65-1-FEM-TULIP G52917 E3826004 1082700252917220220226E3826004 IGTCFS-65-1-FEM-TULIP G52917 E3826512 1082700252917220220227E3826512 IGTCFS-65-1-FEM-TULIP G52917 E3826938 1082700252917220220228E3826938 IGTCFS-65-1-JUG-TULIP G52916 E3819879 1082700252916520220201E3819879 IGTCFS-65-1-JUG-TULIP G52916 E3819880 1082700252916520220201E3819880 IGTCFS-65-1-JUG-TULIP G52916 E3820105 1082700252916520220204E3820105 IGTCFS-65-1-JUG-TULIP G52916 E3820736 1082700252916520220206E3820736 IGTCFS-65-1-JUG-TULIP G52916 E3820824 1082700252916520220206E3820824 IGTCFS-65-1-JUG-TULIP G52916 E3821141 1082700252916520220207E3821141 IGTCFS-65-1-JUG-TULIP G52916 E3821812 1082700252916520220211E3821812 IGTCFS-65-1-JUG-TULIP G52916 E3822124 1082700252916520220212E3822124 IGTCFS-65-1-JUG-TULIP G52916 E3822544 1082700252916520220213E3822544 IGTCFS-65-1-JUG-TULIP G52916 E3823251 1082700252916520220215E3823251 IGTCFS-65-1-JUG-TULIP G52916 E3825280 1082700252916520220225E3825280 IGTCFS-65-1-JUG-TULIP G52916 E3825903 1082700252916520220226E3825903 IGTCFS-65-1-JUG-TULIP G52916 E3825939 1082700252916520220226E3825939 IGTCFS-65-1-JUG-TULIP G52916 E3826432 1082700252916520220227E3826432 IGTCFS-65-1-JUG-TULIP G52916 E3826939 1082700252916520220228E3826939 IGTCFS-65-1-UNI-TULIP G52918 E3830691 1082700252918920220312E3830691 IGTCFS-65-1-UNI-TULIP G52918 E3830692 1082700252918920220312E3830692 IGTCFS-65-1-UNI-TULIP G52918 E3831343 1082700252918920220313E3831343 IGTCFS-65-1-UNI-TULIP G52918 E3832271 1082700252918920220315E3832271 IGTCFS-65-1-UNI-TULIP G52918 E3832885 1082700252918920220318E3832885 IGTCFS-65-1-UNI-TULIP G52918 E3833908 1082700252918920220320E3833908 IGTCFS-65-1-UNI-TULIP G52918 E3836608 1082700252918920220327E3836608 IGTCFS-65-1-UNI-TULIP G52918 E3837201 1082700252918920220328E3837201 IGTCFS-65-1-FEM-TULIP G52917 E3827399 1082700252917220220301E3827399 IGTCFS-65-1-FEM-TULIP G52917 E3831235 1082700252917220220313E3831235 IGTCFS-65-1-FEM-TULIP G52917 E3831777 1082700252917220220314E3831777 IGTCFS-65-1-FEM-TULIP G52917 E3831845 1082700252917220220314E3831845 IGTCFS-65-1-FEM-TULIP G52917 E3832884 1082700252917220220318E3832884 IGTCFS-65-1-FEM-TULIP G52917 E3833491 1082700252917220220319E3833491 IGTCFS-65-1-FEM-TULIP G52917 E3833996 1082700252917220220320E3833996 IGTCFS-65-1-FEM-TULIP G52917 E3835423 1082700252917220220325E3835423 IGTCFS-65-1-FEM-TULIP G52917 E3835494 1082700252917220220325E3835494 IGTCFS-65-1-FEM-TULIP G52917 E3836013 1082700252917220220326E3836013 IGTCFS-65-1-FEM-TULIP G52917 E3836636 1082700252917220220327E3836636 IGTCFS-65-1-FEM-TULIP G52917 E3837153 1082700252917220220328E3837153 IGTCFS-65-1-FEM-TULIP G52917 E3838005 1082700252917220220329E3838005 IGTCFS-65-1-JUG-TULIP G52916 E3827747 1082700252916520220304E3827747 IGTCFS-65-1-JUG-TULIP G52916 E3831778 1082700252916520220314E3831778 IGTCFS-65-1-JUG-TULIP G52916 E3832304 1082700252916520220315E3832304 IGTCFS-65-1-JUG-TULIP G52916 E3833437 1082700252916520220319E3833437 IGTCFS-65-1-JUG-TULIP G52916 E3833505 1082700252916520220319E3833505 IGTCFS-65-1-JUG-TULIP G52916 E3833536 1082700252916520220319E3833536 IGTCFS-65-1-JUG-TULIP G52916 E3834015 1082700252916520220320E3834015 IGTCFS-65-1-JUG-TULIP G52916 E3835562 1082700252916520220325E3835562 IGTCFS-65-1-JUG-TULIP G52916 E3836157 1082700252916520220326E3836157 IGTCFS-65-1-JUG-TULIP G52916 E3836517 1082700252916520220327E3836517 IGTCFS-65-1-JUG-TULIP G52916 E3837955 1082700252916520220329E3837955 IGTCFS-65-1-JUG-TULIP G52916 E3838006 1082700252916520220329E3838006 IGTCFS-65-1-UNI-TULIP G52918 E3838873 1082700252918920220402E3838873 IGTCFS-65-1-UNI-TULIP G52918 E3839398 1082700252918920220403E3839398 IGTCFS-65-1-UNI-TULIP G52918 E3841740 1082700252918920220409E3841740 IGTCFS-65-1-UNI-TULIP G52918 E3843594 1082700252918920220412E3843594 IGTCFS-65-1-UNI-TULIP G52918 E3846865 1082700252918920220426E3846865 IGTCFS-65-1-UNI-TULIP G52918 E3847342 1082700252918920220429E3847342 IGTCFS-65-1-FEM-TULIP G52917 E3838416 1082700252917220220401E3838416 IGTCFS-65-1-FEM-TULIP G52917 E3838923 1082700252917220220402E3838923 IGTCFS-65-1-FEM-TULIP G52917 E3840225 1082700252917220220404E3840225 IGTCFS-65-1-FEM-TULIP G52917 E3840828 1082700252917220220405E3840828 IGTCFS-65-1-FEM-TULIP G52917 E3841731 1082700252917220220409E3841731 IGTCFS-65-1-FEM-TULIP G52917 E3842191 1082700252917220220410E3842191 IGTCFS-65-1-FEM-TULIP G52917 E3843633 1082700252917220220412E3843633 IGTCFS-65-1-FEM-TULIP G52917 E3844250 1082700252917220220416E3844250 IGTCFS-65-1-FEM-TULIP G52917 E3844561 1082700252917220220417E3844561 IGTCFS-65-1-FEM-TULIP G52917 E3845029 1082700252917220220423E3845029 IGTCFS-65-1-FEM-TULIP G52917 E3845680 1082700252917220220424E3845680 IGTCFS-65-1-FEM-TULIP G52917 E3846894 1082700252917220220426E3846894 IGTCFS-65-1-FEM-TULIP G52917 E3847303 1082700252917220220429E3847303 IGTCFS-65-1-FEM-TULIP G52917 E3847748 1082700252917220220430E3847748 IGTCFS-65-1-JUG-TULIP G52916 E3838383 1082700252916520220401E3838383 IGTCFS-65-1-JUG-TULIP G52916 E3838874 1082700252916520220402E3838874 IGTCFS-65-1-JUG-TULIP G52916 E3840814 1082700252916520220405E3840814 IGTCFS-65-1-JUG-TULIP G52916 E3841694 1082700252916520220409E3841694 IGTCFS-65-1-JUG-TULIP G52916 E3841695 1082700252916520220409E3841695 IGTCFS-65-1-JUG-TULIP G52916 E3842192 1082700252916520220410E3842192 IGTCFS-65-1-JUG-TULIP G52916 E3844512 1082700252916520220417E3844512 IGTCFS-65-1-JUG-TULIP G52916 E3844513 1082700252916520220417E3844513 IGTCFS-65-1-JUG-TULIP G52916 E3846247 1082700252916520220425E3846247 IGTCFS-65-1-JUG-TULIP G52916 E3847246 1082700252916520220429E3847246 IGTCFS-65-1-UNI-TULIP G52918 E3848786 1082700252918920220502E3848786 IGTCFS-65-1-UNI-TULIP G52918 E3850691 1082700252918920220507E3850691 IGTCFS-65-1-UNI-TULIP G52918 E3855390 1082700252918920220521E3855390 IGTCFS-65-1-UNI-TULIP G52918 E3857284 1082700252918920220524E3857284 IGTCFS-65-1-UNI-TULIP G52918 E3859338 1082700252918920220531E3859338 IGTCFS-65-1-FEM-TULIP G52917 E3848711 1082700252917220220502E3848711 IGTCFS-65-1-FEM-TULIP G52917 E3849811 1082700252917220220506E3849811 IGTCFS-65-1-FEM-TULIP G52917 E3850306 1082700252917220220507E3850306 IGTCFS-65-1-FEM-TULIP G52917 E3850307 1082700252917220220507E3850307 IGTCFS-65-1-FEM-TULIP G52917 E3851540 1082700252917220220509E3851540 IGTCFS-65-1-FEM-TULIP G52917 E3851541 1082700252917220220509E3851541 IGTCFS-65-1-FEM-TULIP G52917 E3855832 1082700252917220220522E3855832 IGTCFS-65-1-FEM-TULIP G52917 E3857907 1082700252917220220527E3857907 IGTCFS-65-1-FEM-TULIP G52917 E3858477 1082700252917220220528E3858477 IGTCFS-65-1-FEM-TULIP G52917 E3859131 1082700252917220220529E3859131 IGTCFS-65-1-FEM-TULIP G52917 E3859351 1082700252917220220531E3859351 IGTCFS-65-1-JUG-TULIP G52916 E3848066 1082700252916520220501E3848066 IGTCFS-65-1-JUG-TULIP G52916 E3848073 1082700252916520220501E3848073 IGTCFS-65-1-JUG-TULIP G52916 E3848819 1082700252916520220502E3848819 IGTCFS-65-1-JUG-TULIP G52916 E3849561 1082700252916520220506E3849561 IGTCFS-65-1-JUG-TULIP G52916 E3850454 1082700252916520220507E3850454 IGTCFS-65-1-JUG-TULIP G52916 E3850690 1082700252916520220508E3850690 IGTCFS-65-1-JUG-TULIP G52916 E3851347 1082700252916520220509E3851347 IGTCFS-65-1-JUG-TULIP G52916 E3851348 1082700252916520220509E3851348 IGTCFS-65-1-JUG-TULIP G52916 E3851893 1082700252916520220510E3851893 IGTCFS-65-1-JUG-TULIP G52916 E3856529 1082700252916520220523E3856529 IGTCFS-65-1-JUG-TULIP G52916 E3857936 1082700252916520220527E3857936 IGTCFS-65-1-JUG-TULIP G52916 E3858370 1082700252916520220528E3858370 IGTCFS-65-1-JUG-TULIP G52916 E3859132 1082700252916520220529E3859132 IGTCFS-65-1-UNI-TULIP G52918 E3860499 1082700252918920220604E3860499 IGTCFS-65-1-UNI-TULIP G52918 E3861511 1082700252918920220607E3861511 IGTCFS-65-1-UNI-TULIP G52918 E3862912 1082700252918920220612E3862912 IGTCFS-65-1-UNI-TULIP G52918 E3864792 1082700252918920220617E3864792 IGTCFS-65-1-UNI-TULIP G52918 E3866427 1082700252918920220619E3866427 IGTCFS-65-1-UNI-TULIP G52918 E3867167 1082700252918920220621E3867167 IGTCFS-65-1-UNI-TULIP G52918 E3869595 1082700252918920220627E3869595 IGTCFS-65-1-FEM-TULIP G52917 E3859845 (01)10827002529172(17)220306(10)E3859845 IGTCFS-65-1-FEM-TULIP G52917 E3860395 1082700252917220220604E3860395 IGTCFS-65-1-FEM-TULIP G52917 E3861510 1082700252917220220607E3861510 IGTCFS-65-1-FEM-TULIP G52917 E3862082 1082700252917220220611E3862082 IGTCFS-65-1-FEM-TULIP G52917 E3862911 1082700252917220220612E3862911 IGTCFS-65-1-FEM-TULIP G52917 E3863953 1082700252917220220614E3863953 IGTCFS-65-1-FEM-TULIP G52917 E3865557 1082700252917220220618E3865557 IGTCFS-65-1-FEM-TULIP G52917 E3866116 1082700252917220220619E3866116 IGTCFS-65-1-FEM-TULIP G52917 E3867856 1082700252917220220624E3867856 IGTCFS-65-1-FEM-TULIP G52917 E3868500 1082700252917220220625E3868500 IGTCFS-65-1-FEM-TULIP G52917 E3868997 1082700252917220220626E3868997 IGTCFS-65-1-FEM-TULIP G52917 E3869594 1082700252917220220627E3869594 IGTCFS-65-1-JUG-TULIP G52916 E3859697 1082700252916520220603E3859697 IGTCFS-65-1-JUG-TULIP G52916 E3860406 1082700252916520220604E3860406 IGTCFS-65-1-JUG-TULIP G52916 E3860442 1082700252916520220604E3860442 IGTCFS-65-1-JUG-TULIP G52916 E3860443 1082700252916520220604E3860443 IGTCFS-65-1-JUG-TULIP G52916 E3862110 1082700252916520220611E3862110 IGTCFS-65-1-JUG-TULIP G52916 E3863563 1082700252916520220613E3863563 IGTCFS-65-1-JUG-TULIP G52916 E3865448 1082700252916520220618E3865448 IGTCFS-65-1-JUG-TULIP G52916 E3865558 1082700252916520220618E3865558 IGTCFS-65-1-JUG-TULIP G52916 E3866779 1082700252916520220620E3866779 IGTCFS-65-1-JUG-TULIP G52916 E3867857 1082700252916520220624E3867857 IGTCFS-65-1-JUG-TULIP G52916 E3868422 108270025... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Feb 14, 2022
- Center classification date
- Apr 6, 2022
- Termination date
- Nov 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.