Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502;...
FDA Device Recall #Z-0876-2022 — Class III — February 14, 2022
Recall Summary
| Recall Number | Z-0876-2022 |
| Classification | Class III — Low risk |
| Date Initiated | February 14, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Medical Incorporated |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 52,590 units |
Product Description
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
Distribution Pattern
US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
Lot / Code Information
All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration range from January 8, 2022 through January 18 2025. IGTCFS-65-1-UNI-CELECT-PT G34505 E3814946 (01)10827002345055(17)221501(10)E3814946 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819087 (01)10827002345055(17)223001(10)E3819087 IGTCFS-65-1-UNI-CELECT-PT G34505 E3814444 1082700234505520220114E3814444 IGTCFS-65-1-UNI-CELECT-PT G34505 E3814546 1082700234505520220114E3814546 IGTCFS-65-1-UNI-CELECT-PT G34505 E3815516 1082700234505520220116E3815516 IGTCFS-65-1-UNI-CELECT-PT G34505 E3815843 1082700234505520220122E3815843 IGTCFS-65-1-UNI-CELECT-PT G34505 E3815844 1082700234505520220122E3815844 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817094 1082700234505520220123E3817094 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817095 1082700234505520220123E3817095 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817236 1082700234505520220123E3817236 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817237 1082700234505520220123E3817237 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817548 1082700234505520220124E3817548 IGTCFS-65-1-UNI-CELECT-PT G34505 E3818452 1082700234505520220128E3818452 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819086 1082700234505520220130E3819086 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819413 1082700234505520220131E3819413 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814443 1082700234502420220114E3814443 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814487 1082700234502420220114E3814487 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814545 1082700234502420220114E3814545 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814856 1082700234502420220115E3814856 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814857 1082700234502420220115E3814857 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814912 1082700234502420220115E3814912 IGTCFS-65-1-FEM-CELECT-PT G34502 E3814913 1082700234502420220115E3814913 IGTCFS-65-1-FEM-CELECT-PT G34502 E3815515 1082700234502420220116E3815515 IGTCFS-65-1-FEM-CELECT-PT G34502 E3815882 1082700234502420220122E3815882 IGTCFS-65-1-FEM-CELECT-PT G34502 E3815883 1082700234502420220122E3815883 IGTCFS-65-1-FEM-CELECT-PT G34502 E3817258 1082700234502420220123E3817258 IGTCFS-65-1-FEM-CELECT-PT G34502 E3817259 1082700234502420220123E3817259 IGTCFS-65-1-FEM-CELECT-PT G34502 E3817537 1082700234502420220124E3817537 IGTCFS-65-1-FEM-CELECT-PT G34502 E3817538 1082700234502420220124E3817538 IGTCFS-65-1-FEM-CELECT-PT G34502 E3817877 1082700234502420220125E3817877 IGTCFS-65-1-FEM-CELECT-PT G34502 E3818493 1082700234502420220128E3818493 IGTCFS-65-1-FEM-CELECT-PT G34502 E3818693 1082700234502420220129E3818693 IGTCFS-65-1-FEM-CELECT-PT G34502 E3818694 1082700234502420220129E3818694 IGTCFS-65-1-FEM-CELECT-PT G34502 E3819225 1082700234502420220130E3819225 IGTCFS-65-1-FEM-CELECT-PT G34502 E3819578 1082700234502420220131E3819578 IGTCFS-65-1-FEM-CELECT-PT G34502 E3819579 1082700234502420220131E3819579 IGTCFS-65-1-FEM-CELECT-PT G34502 E3819580 1082700234502420220131E3819580 IGTCFS-65-1-FEM-CELECT-PT G34502 E3819581 1082700234502420220131E3819581 IGTCFS-65-1-JUG-CELECT-PT G34309 E3812820 1082700234309920220108E3812820 IGTCFS-65-1-JUG-CELECT-PT G34309 E3813773 1082700234309920220110E3813773 IGTCFS-65-1-JUG-CELECT-PT G34309 E3814877 1082700234309920220115E3814877 IGTCFS-65-1-JUG-CELECT-PT G34309 E3815458 1082700234309920220116E3815458 IGTCFS-65-1-JUG-CELECT-PT G34309 E3815482 1082700234309920220116E3815482 IGTCFS-65-1-JUG-CELECT-PT G34309 E3815483 1082700234309920220116E3815483 IGTCFS-65-1-JUG-CELECT-PT G34309 E3815832 1082700234309920220122E3815832 IGTCFS-65-1-JUG-CELECT-PT G34309 E3815865 1082700234309920220122E3815865 IGTCFS-65-1-JUG-CELECT-PT G34309 E3817485 1082700234309920220124E3817485 IGTCFS-65-1-JUG-CELECT-PT G34309 E3818381 1082700234309920220128E3818381 IGTCFS-65-1-JUG-CELECT-PT G34309 E3818382 1082700234309920220128E3818382 IGTCFS-65-1-JUG-CELECT-PT G34309 E3819042 1082700234309920220130E3819042 IGTCFS-65-1-JUG-CELECT-PT G34309 E3819043 1082700234309920220130E3819043 IGTCFS-65-1-JUG-CELECT-PT G34309 E3819459 1082700234309920220131E3819459 IGTCFS-65-1-JUG-CELECT-PT G34309 E3819460 1082700234309920220131E3819460 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819844 1082700234505520220201E3819844 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819906 1082700234505520220201E3819906 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819988 1082700234505520220204E3819988 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819989 1082700234505520220204E3819989 IGTCFS-65-1-UNI-CELECT-PT G34505 E3820728 1082700234505520220206E3820728 IGTCFS-65-1-UNI-CELECT-PT G34505 E3820729 1082700234505520220206E3820729 IGTCFS-65-1-UNI-CELECT-PT G34505 E3820784 1082700234505520220206E3820784 IGTCFS-65-1-UNI-CELECT-PT G34505 E3821068 1082700234505520220207E3821068 IGTCFS-65-1-UNI-CELECT-PT G34505 E3821069 1082700234505520220207E3821069 IGTCFS-65-1-UNI-CELECT-PT G34505 E3821747 1082700234505520220211E3821747 IGTCFS-65-1-UNI-CELECT-PT G34505 E3821748 1082700234505520220211E3821748 IGTCFS-65-1-UNI-CELECT-PT G34505 E3822099 1082700234505520220212E3822099 IGTCFS-65-1-UNI-CELECT-PT G34505 E3822135 1082700234505520220212E3822135 IGTCFS-65-1-UNI-CELECT-PT G34505 E3822854 1082700234505520220214E3822854 IGTCFS-65-1-UNI-CELECT-PT G34505 E3823207 1082700234505520220215E3823207 IGTCFS-65-1-UNI-CELECT-PT G34505 E3825222 1082700234505520220225E3825222 IGTCFS-65-1-UNI-CELECT-PT G34505 E3825970 1082700234505520220226E3825970 IGTCFS-65-1-UNI-CELECT-PT G34505 E3826005 1082700234505520220226E3826005 IGTCFS-65-1-UNI-CELECT-PT G34505 E3826549 1082700234505520220227E3826549 IGTCFS-65-1-UNI-CELECT-PT G34505 E3826897 1082700234505520220228E3826897 IGTCFS-65-1-UNI-CELECT-PT G34505 E3826898 1082700234505520220228E3826898 IGTCFS-65-1-FEM-CELECT-PT G34502 E3820251 1082700234502420220204E3820251 IGTCFS-65-1-FEM-CELECT-PT G34502 E3820517 1082700234502420220205E3820517 IGTCFS-65-1-FEM-CELECT-PT G34502 E3820518 1082700234502420220205E3820518 IGTCFS-65-1-FEM-CELECT-PT G34502 E3820773 1082700234502420220206E3820773 IGTCFS-65-1-FEM-CELECT-PT G34502 E3820774 1082700234502420220206E3820774 IGTCFS-65-1-FEM-CELECT-PT G34502 E3821155 1082700234502420220207E3821155 IGTCFS-65-1-FEM-CELECT-PT G34502 E3821446 1082700234502420220208E3821446 IGTCFS-65-1-FEM-CELECT-PT G34502 E3821447 1082700234502420220208E3821447 IGTCFS-65-1-FEM-CELECT-PT G34502 E3821462 1082700234502420220208E3821462 IGTCFS-65-1-FEM-CELECT-PT G34502 E3821705 1082700234502420220211E3821705 IGTCFS-65-1-FEM-CELECT-PT G34502 E3821706 1082700234502420220211E3821706 IGTCFS-65-1-FEM-CELECT-PT G34502 E3822073 1082700234502420220212E3822073 IGTCFS-65-1-FEM-CELECT-PT G34502 E3822074 1082700234502420220212E3822074 IGTCFS-65-1-FEM-CELECT-PT G34502 E3822503 1082700234502420220213E3822503 IGTCFS-65-1-FEM-CELECT-PT G34502 E3822504 1082700234502420220213E3822504 IGTCFS-65-1-FEM-CELECT-PT G34502 E3822882 1082700234502420220214E3822882 IGTCFS-65-1-FEM-CELECT-PT G34502 E3822897 1082700234502420220214E3822897 IGTCFS-65-1-FEM-CELECT-PT G34502 E3823235 1082700234502420220215E3823235 IGTCFS-65-1-FEM-CELECT-PT G34502 E3825268 1082700234502420220225E3825268 IGTCFS-65-1-FEM-CELECT-PT G34502 E3825976 1082700234502420220226E3825976 IGTCFS-65-1-FEM-CELECT-PT G34502 E3825977 1082700234502420220226E3825977 IGTCFS-65-1-FEM-CELECT-PT G34502 E3826358 1082700234502420220227E3826358 IGTCFS-65-1-FEM-CELECT-PT G34502 E3826359 1082700234502420220227E3826359 IGTCFS-65-1-FEM-CELECT-PT G34502 E3826511 1082700234502420220227E3826511 IGTCFS-65-1-FEM-CELECT-PT G34502 E3826947 1082700234502420220228E3826947 IGTCFS-65-1-JUG-CELECT-PT G34309 E3826886 (01)10827002343099(17)222802(10)E3826886 IGTCFS-65-1-JUG-CELECT-PT G34309 E3820021 1082700234309920220204E3820021 IGTCFS-65-1-JUG-CELECT-PT G34309 E3820451 1082700234309920220205E3820451 IGTCFS-65-1-JUG-CELECT-PT G34309 E3820452 1082700234309920220205E3820452 IGTCFS-65-1-JUG-CELECT-PT G34309 E3820497 1082700234309920220205E3820497 IGTCFS-65-1-JUG-CELECT-PT G34309 E3820532 1082700234309920220205E3820532 IGTCFS-65-1-JUG-CELECT-PT G34309 E3820737 1082700234309920220206E3820737 IGTCFS-65-1-JUG-CELECT-PT G34309 E3821042 1082700234309920220207E3821042 IGTCFS-65-1-JUG-CELECT-PT G34309 E3821044 1082700234309920220207E3821044 IGTCFS-65-1-JUG-CELECT-PT G34309 E3821547 1082700234309920220208E3821547 IGTCFS-65-1-JUG-CELECT-PT G34309 E3822116 1082700234309920220212E3822116 IGTCFS-65-1-JUG-CELECT-PT G34309 E3822117 1082700234309920220212E3822117 IGTCFS-65-1-JUG-CELECT-PT G34309 E3822485 1082700234309920220213E3822485 IGTCFS-65-1-JUG-CELECT-PT G34309 E3822512 1082700234309920220213E3822512 IGTCFS-65-1-JUG-CELECT-PT G34309 E3822872 1082700234309920220214E3822872 IGTCFS-65-1-JUG-CELECT-PT G34309 E3823250 1082700234309920220215E3823250 IGTCFS-65-1-JUG-CELECT-PT G34309 E3825108 1082700234309920220225E3825108 IGTCFS-65-1-JUG-CELECT-PT G34309 E3825902 1082700234309920220226E3825902 IGTCFS-65-1-JUG-CELECT-PT G34309 E3825938 1082700234309920220226E3825938 IGTCFS-65-1-JUG-CELECT-PT G34309 E3826431 1082700234309920220227E3826431 IGTCFS-65-1-JUG-CELECT-PT G34309 E3826497 1082700234309920220227E3826497 IGTCFS-65-1-JUG-CELECT-PT G34309 E3826885 1082700234309920220228E3826885 IGTCFS-65-1-UNI-CELECT-PT G34505 E3827372 1082700234505520220301E3827372 IGTCFS-65-1-UNI-CELECT-PT G34505 E3827591 1082700234505520220304E3827591 IGTCFS-65-1-UNI-CELECT-PT G34505 E3830711 1082700234505520220312E3830711 IGTCFS-65-1-UNI-CELECT-PT G34505 E3830712 1082700234505520220312E3830712 IGTCFS-65-1-UNI-CELECT-PT G34505 E3831181 1082700234505520220313E3831181 IGTCFS-65-1-UNI-CELECT-PT G34505 E3831182 1082700234505520220313E3831182 IGTCFS-65-1-UNI-CELECT-PT G34505 E3831633 1082700234505520220314E3831633 IGTCFS-65-1-UNI-CELECT-PT G34505 E3831846 1082700234505520220314E3831846 IGTCFS-65-1-UNI-CELECT-PT G34505 E3832334 1082700234505520220318E3832334 IGTCFS-65-1-UNI-CELECT-PT G34505 E3833905 1082700234505520220321E3833905 IGTCFS-65-1-UNI-CELECT-PT G34505 E3834520 1082700234505520220321E3834520 IGTCFS-65-1-UNI-CELECT-PT G34505 E3834649 1082700234505520220321E3834649 IGTCFS-65-1-UNI-CELECT-PT G34505 E3834987 1082700234505520220322E3834987 IGTCFS-65-1-UNI-CELECT-PT G34505 E3834988 1082700234505520220322E3834988 IGTCFS-65-1-UNI-CELECT-PT G34505 E3835644 1082700234505520220325E3835644 IGTCFS-65-1-UNI-CELECT-PT G34505 E3835658 1082700234505520220326E3835658 IGTCFS-65-1-UNI-CELECT-PT G34505 E3836156 1082700234505520220326E3836156 IGTCFS-65-1-UNI-CELECT-PT G34505 E3836130 1082700234505520220327E3836130 IGTCFS-65-1-UNI-CELECT-PT G34505 E3836491 1082700234505520220327E3836491 IGTCFS-65-1-UNI-CELECT-PT G34505 E3836518 1082700234505520220327E3836518 IGTCFS-65-1-UNI-CELECT-PT G34505 E3836609 1082700234505520220327E3836609 IGTCFS-65-1-UNI-CELECT-PT G34505 E3837184 1082700234505520220328E3837184 IGTCFS-65-1-UNI-CELECT-PT G34505 E3837975 1082700234505520220329E3837975 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836415 (01)10827002345024(17)222703(10)E3836415 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836623 (01)10827002345024(17)222703(10)E3836623 IGTCFS-65-1-FEM-CELECT-PT G34502 E3827358 1082700234502420220301E3827358 IGTCFS-65-1-FEM-CELECT-PT G34502 E3827359 1082700234502420220301E3827359 IGTCFS-65-1-FEM-CELECT-PT G34502 E3827689 1082700234502420220304E3827689 IGTCFS-65-1-FEM-CELECT-PT G34502 E3827724 1082700234502420220304E3827724 IGTCFS-65-1-FEM-CELECT-PT G34502 E3827725 1082700234502420220304E3827725 IGTCFS-65-1-FEM-CELECT-PT G34502 E3830721 1082700234502420220312E3830721 IGTCFS-65-1-FEM-CELECT-PT G34502 E3830764 1082700234502420220312E3830764 IGTCFS-65-1-FEM-CELECT-PT G34502 E3831767 1082700234502420220314E3831767 IGTCFS-65-1-FEM-CELECT-PT G34502 E3831768 1082700234502420220314E3831768 IGTCFS-65-1-FEM-CELECT-PT G34502 E3832843 1082700234502420220318E3832843 IGTCFS-65-1-FEM-CELECT-PT G34502 E3832844 1082700234502420220318E3832844 IGTCFS-65-1-FEM-CELECT-PT G34502 E3833021 1082700234502420220318E3833021 IGTCFS-65-1-FEM-CELECT-PT G34502 E3833075 1082700234502420220318E3833075 IGTCFS-65-1-FEM-CELECT-PT G34502 E3833470 1082700234502420220319E3833470 IGTCFS-65-1-FEM-CELECT-PT G34502 E3833483 1082700234502420220319E3833483 IGTCFS-65-1-FEM-CELECT-PT G34502 E3833958 1082700234502420220320E3833958 IGTCFS-65-1-FEM-CELECT-PT G34502 E3833986 1082700234502420220320E3833986 IGTCFS-65-1-FEM-CELECT-PT G34502 E3834028 1082700234502420220320E3834028 IGTCFS-65-1-FEM-CELECT-PT G34502 E3834029 1082700234502420220320E3834029 IGTCFS-65-1-FEM-CELECT-PT G34502 E3835625 1082700234502420220325E3835625 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836012 1082700234502420220326E3836012 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836025 1082700234502420220326E3836025 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836026 1082700234502420220326E3836026 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836416 1082700234502420220327E3836416 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836624 1082700234502420220327E3836624 IGTCFS-65-1-FEM-CELECT-PT G34502 E3837154 1082700234502420220328E3837154 IGTCFS-65-1-FEM-CELECT-PT G34502 E3837213 1082700234502420220328E3837213 IGTCFS-65-1-FEM-CELECT-PT G34502 E3837937 1082700234502420220329E3837937 IGTCFS-65-1-JUG-CELECT-PT G34309 E3831735 (01)10827002343099(17)221403(10)E3831735 IGTCFS-65-1-JUG-CELECT-PT G34309 E3836010 (01)10827002343099(17)222603(10)E3836010 IGTCFS-65-1-JUG-CELECT-PT G34309 E3827590 1082700234309920220304E3827590 IGTCFS-65-1-JUG-CELECT-PT G34309 E3827677 1082700234309920220304E3827677 IGTCFS-65-1-JUG-CELECT-PT G34309 E3830722 1082700234309920220312E3830722 IGTCFS-65-1-JUG-CELECT-PT G34309 E3831361 1082700234309920220313E3831361 IGTCFS-65-1-JUG-CELECT-PT G34309 E3832303 1082700234309920220315E3832303 IGTCFS-65-1-JUG-CELECT-PT G34309 E3832865 1082700234309920220318E3832865 IGTCFS-65-1-JUG-CELECT-PT G34309 E3832866 1082700234309920220318E3832866 IGTCFS-65-1-JUG-CELECT-PT G34309 E3833022 1082700234309920220318E3833022 IGTCFS-65-1-JUG-CELECT-PT G34309 E3833492 1082700234309920220319E3833492 IGTCFS-65-1-JUG-CELECT-PT G34309 E3833504 1082700234309920220319E3833504 IGTCFS-65-1-JUG-CELECT-PT G34309 E3833904 1082700234309920220320E3833904 IGTCFS-65-1-JUG-CELECT-PT G34309 E3833997 1082700234309920220320E3833997 IGTCFS-65-1-JUG-CELECT-PT G34309 E3835041 1082700234309920220322E3835041 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1082700234505520220402E3838813 IGTCFS-65-1-UNI-CELECT-PT G34505 E3838814 1082700234505520220402E3838814 IGTCFS-65-1-UNI-CELECT-PT G34505 E3838893 1082700234505520220402E3838893 IGTCFS-65-1-UNI-CELECT-PT G34505 E3839213 1082700234505520220403E3839213 IGTCFS-65-1-UNI-CELECT-PT G34505 E3839214 1082700234505520220403E3839214 IGTCFS-65-1-UNI-CELECT-PT G34505 E3839372 1082700234505520220403E3839372 IGTCFS-65-1-UNI-CELECT-PT G34505 E3839373 1082700234505520220403E3839373 IGTCFS-65-1-UNI-CELECT-PT G34505 E3839988 1082700234505520220404E3839988 IGTCFS-65-1-UNI-CELECT-PT G34505 E3839989 1082700234505520220404E3839989 IGTCFS-65-1-UNI-CELECT-PT G34505 E3840136 1082700234505520220404E3840136 IGTCFS-65-1-UNI-CELECT-PT G34505 E3840192 1082700234505520220404E3840192 IGTCFS-65-1-UNI-CELECT-PT G34505 E3840731 1082700234505520220405E3840731 IGTCFS-65-1-UNI-CELECT-PT G34505 E3840732 1082700234505520220405E3840732 IGTCFS-65-1-UNI-CELECT-PT G34505 E3841046 1082700234505520220408E3841046 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1082700234502420220614E3863952 IGTCFS-65-1-FEM-CELECT-PT G34502 E3865629 1082700234502420220618E3865629 IGTCFS-65-1-FEM-CELECT-PT G34502 E3865630 1082700234502420220618E3865630 IGTCFS-65-1-FEM-CELECT-PT G34502 E3865650 1082700234502420220618E3865650 IGTCFS-65-1-FEM-CELECT-PT G34502 E3866063 1082700234502420220619E3866063 IGTCFS-65-1-FEM-CELECT-PT G34502 E3866780 1082700234502420220620E3866780 IGTCFS-65-1-FEM-CELECT-PT G34502 E3867168 1082700234502420220621E3867168 IGTCFS-65-1-FEM-CELECT-PT G34502 E3867927 1082700234502420220624E3867927 IGTCFS-65-1-FEM-CELECT-PT G34502 E3868466 1082700234502420220625E3868466 IGTCFS-65-1-FEM-CELECT-PT G34502 E3868467 1082700234502420220625E3868467 IGTCFS-65-1-FEM-CELECT-PT G34502 E3868489 1082700234502420220625E3868489 IGTCFS-65-1-FEM-CELECT-PT G34502 E3868882 1082700234502420220626E3868882 IGTCFS-65-1-FEM-CELECT-PT G34502 E3868883 1082700234502420220626E3868883 IGTCFS-65-1-FEM-CELECT-PT G34502 E3869467 1082700234502420220627E3869467 IGTCFS-65-1-FEM-CELECT-PT G34502 E3869468 1082700234502420220627E3869468 IGTCFS-65-1-FEM-CELECT-PT G34502 E3869540 1082700234502420220627E3869540 IGTCFS-65-1-JUG-CELECT-PT G34309 E3868341 (01)10827002343099(17)222506(10)E3868341 IGTCFS-65-1-JUG-CELECT-PT G34309 E3859698 1082700234309920220603E3859698 IGTCFS-65-1-JUG-CELECT-PT G34309 E3860405 1082700234309920220604E3860405 IGTCFS-65-1-JUG-CELECT-PT G34309 E3861063 1082700234309920220606E3861063 IGTCFS-65-1-JUG-CELECT-PT G34309 E3861064 1082700234309920220606E3861064 IGTCFS-65-1-JUG-CELECT-PT G34309 E3861485 1082700234309920220607E3861485 IGTCFS-65-1-JUG-CELECT-PT G34309 E3861486 1082700234309920220611E3861486 IGTCFS-65-1-JUG-CELECT-PT G34309 E3862169 1082700234309920220611E3862169 IGTCFS-65-1-JUG-CELECT-PT G34309 E3862196 1082700234309920220611E3862196 IGTCFS-65-1-JUG-CELECT-PT G34309 E3862826 1082700234309920220612E3862826 IGTCFS-65-1-JUG-CELECT-PT G34309 E3863886 1082700234309920220614E3863886 IGTCFS-65-1-JUG-CELECT-PT G34309 E3864959 1082700234309920220617E3864959 IGTCFS-65-1-JUG-CELECT-PT G34309 E3864960 1082700234309920220617E3864960 IGTCFS-65-1-JUG-CELECT-PT G34309 E3865449 1082700234309920220618E3865449 IGTCFS-65-1-JUG-CELECT-PT G34309 E3866391 1082700234309920220619E3866391 IGTCFS-65-1-JUG-CELECT-PT G34309 E3866686 1082700234309920220620E3866686 IGTCFS-65-1-JUG-CELECT-PT G34309 E3866687 1082700234309920220620E3866687 IGTCFS-65-1-JUG-CELECT-PT G34309 E3867135 1082700234309920220621E3867135 IGTCFS-65-1-JUG-CELECT-PT G34309 E3867136 1082700234309920220621E3867136 IGTCFS-65-1-JUG-CELECT-PT G34309 E3868501 1082700234309920220625E3868501 IGTCFS-65-1-JUG-CELECT-PT G34309 E3869043 1082700234309920220626E3869043 IGTCFS-65-1-JUG-CELECT-PT G34309 E3869493 1082700234309920220627E3869493 IGTCFS-65-1-JUG-CELECT-PT G34309 E3870092 1082700234309920220628E3870092 IGTCFS-65-1-UNI-CELECT-PT G34505 E3871805 (01)10827002345055(17)220307(10)E3871805 IGTCFS-65-1-UNI-CELECT-PT G34505 E3870587 1082700234505520220701E3870587 IGTCFS-65-1-UNI-CELECT-PT G34505 E3870705 1082700234505520220701E3870705 IGTCFS-65-1-UNI-CELECT-PT G34505 E3871243 1082700234505520220702E3871243 IGTCFS-65-1-UNI-CELECT-PT G34505 E3871244 1082700234505520220702E3871244 IGTCFS-65-1-UNI-CELECT-PT G34505 E3871743 1082700234505520220703E3871743 IGTCFS-65-1-UNI-CELECT-PT G34505 E3871744 1082700234505520220703E3871744 IGTCFS-65-1
Other Recalls from Cook Medical Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0043-2026 | Class I | Zenith Alpha 2 Thoracic Endovascular Graft, Cat... | Sep 18, 2025 |
| Z-1832-2024 | Class II | EchoTip¿ Ultra HD Endoscopic Ultrasound Access ... | Apr 1, 2024 |
| Z-1833-2024 | Class II | EchoTip¿ Ultra Endoscopic Ultrasound Access Nee... | Apr 1, 2024 |
| Z-0875-2022 | Class III | Gunther Tulip Vena Cava Filter Set for Femoral ... | Feb 14, 2022 |
| Z-1026-2019 | Class III | Cook Celect Platinum Vena Cava Filter Set for ... | Feb 25, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.