Reported Apr 13, 2022 · Terminated
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502;…
Cook Medical Incorporated
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Medical Incorporated · 400 N Daniels Way · Bloomington, IN · 47404-9155
Is this the product you have?
- Cook Celect PlatinumVena
- Cava Filter Set Catalog Number/GPN
IGTCFS-65-1-FEM-CELECT-PT G34502IGTCFS-65-1-JUG-CELECT-PT G34309IGTCFS-65-1-UNI-CELECT-PT G34505
- Lot codes and dates
- 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(01)10827002343099(17)222802(10)E3826886
391 of 391 codes
IGTCFS-65-1-UNI-CELECT-PTG34505E38144441082700234505520220114E3814444IGTCFS-65-1-UNI-CELECT-PTG34505E38145461082700234505520220114E3814546IGTCFS-65-1-UNI-CELECT-PTG34505E38155161082700234505520220116E3815516IGTCFS-65-1-UNI-CELECT-PTG34505E38158431082700234505520220122E3815843IGTCFS-65-1-UNI-CELECT-PTG34505E38158441082700234505520220122E3815844IGTCFS-65-1-UNI-CELECT-PTG34505E38170941082700234505520220123E3817094IGTCFS-65-1-UNI-CELECT-PTG34505E38170951082700234505520220123E3817095IGTCFS-65-1-UNI-CELECT-PTG34505E38172361082700234505520220123E3817236IGTCFS-65-1-UNI-CELECT-PTG34505E38172371082700234505520220123E3817237IGTCFS-65-1-UNI-CELECT-PTG34505E38175481082700234505520220124E3817548IGTCFS-65-1-UNI-CELECT-PTG34505E38184521082700234505520220128E3818452IGTCFS-65-1-UNI-CELECT-PTG34505E38190861082700234505520220130E3819086IGTCFS-65-1-UNI-CELECT-PTG34505E38194131082700234505520220131E3819413IGTCFS-65-1-FEM-CELECT-PTG34502E38144431082700234502420220114E3814443IGTCFS-65-1-FEM-CELECT-PTG34502E38144871082700234502420220114E3814487
(01)10827002345024(17)222703(10)E3836415 IGTCFS-65-1-FEM-CELECT-PT G34502 E3836623 (01)10827002345024(17)222703(10)E3836623179 of 179 codes
IGTCFS-65-1-JUG-CELECT-PTG34309E38200211082700234309920220204E3820021IGTCFS-65-1-JUG-CELECT-PTG34309E38204511082700234309920220205E3820451IGTCFS-65-1-JUG-CELECT-PTG34309E38204521082700234309920220205E3820452IGTCFS-65-1-JUG-CELECT-PTG34309E38204971082700234309920220205E3820497IGTCFS-65-1-JUG-CELECT-PTG34309E38205321082700234309920220205E3820532IGTCFS-65-1-JUG-CELECT-PTG34309E38207371082700234309920220206E3820737IGTCFS-65-1-JUG-CELECT-PTG34309E38210421082700234309920220207E3821042IGTCFS-65-1-JUG-CELECT-PTG34309E38210441082700234309920220207E3821044IGTCFS-65-1-JUG-CELECT-PTG34309E38215471082700234309920220208E3821547IGTCFS-65-1-JUG-CELECT-PTG34309E38221161082700234309920220212E3822116IGTCFS-65-1-JUG-CELECT-PTG34309E38221171082700234309920220212E3822117IGTCFS-65-1-JUG-CELECT-PTG34309E38224851082700234309920220213E3822485IGTCFS-65-1-JUG-CELECT-PTG34309E38225121082700234309920220213E3822512IGTCFS-65-1-JUG-CELECT-PTG34309E38228721082700234309920220214E3822872IGTCFS-65-1-JUG-CELECT-PTG34309E38232501082700234309920220215E3823250
(01)10827002343099(17)221403(10)E3831735 IGTCFS-65-1-JUG-CELECT-PT G34309 E3836010 (01)10827002343099(17)222603(10)E3836010115 of 115 codes
IGTCFS-65-1-FEM-CELECT-PTG34502E38273581082700234502420220301E3827358IGTCFS-65-1-FEM-CELECT-PTG34502E38273591082700234502420220301E3827359IGTCFS-65-1-FEM-CELECT-PTG34502E38276891082700234502420220304E3827689IGTCFS-65-1-FEM-CELECT-PTG34502E38277241082700234502420220304E3827724IGTCFS-65-1-FEM-CELECT-PTG34502E38277251082700234502420220304E3827725IGTCFS-65-1-FEM-CELECT-PTG34502E38307211082700234502420220312E3830721IGTCFS-65-1-FEM-CELECT-PTG34502E38307641082700234502420220312E3830764IGTCFS-65-1-FEM-CELECT-PTG34502E38317671082700234502420220314E3831767IGTCFS-65-1-FEM-CELECT-PTG34502E38317681082700234502420220314E3831768IGTCFS-65-1-FEM-CELECT-PTG34502E38328431082700234502420220318E3832843IGTCFS-65-1-FEM-CELECT-PTG34502E38328441082700234502420220318E3832844IGTCFS-65-1-FEM-CELECT-PTG34502E38330211082700234502420220318E3833021IGTCFS-65-1-FEM-CELECT-PTG34502E38330751082700234502420220318E3833075IGTCFS-65-1-FEM-CELECT-PTG34502E38334701082700234502420220319E3833470IGTCFS-65-1-FEM-CELECT-PTG34502E38334831082700234502420220319E3833483
(01)10827002345055(17)222404(10)E384562287 of 87 codes
IGTCFS-65-1-JUG-CELECT-PTG34309E38275901082700234309920220304E3827590IGTCFS-65-1-JUG-CELECT-PTG34309E38276771082700234309920220304E3827677IGTCFS-65-1-JUG-CELECT-PTG34309E38307221082700234309920220312E3830722IGTCFS-65-1-JUG-CELECT-PTG34309E38313611082700234309920220313E3831361IGTCFS-65-1-JUG-CELECT-PTG34309E38323031082700234309920220315E3832303IGTCFS-65-1-JUG-CELECT-PTG34309E38328651082700234309920220318E3832865IGTCFS-65-1-JUG-CELECT-PTG34309E38328661082700234309920220318E3832866IGTCFS-65-1-JUG-CELECT-PTG34309E38330221082700234309920220318E3833022IGTCFS-65-1-JUG-CELECT-PTG34309E38334921082700234309920220319E3833492IGTCFS-65-1-JUG-CELECT-PTG34309E38335041082700234309920220319E3833504IGTCFS-65-1-JUG-CELECT-PTG34309E38339041082700234309920220320E3833904IGTCFS-65-1-JUG-CELECT-PTG34309E38339971082700234309920220320E3833997IGTCFS-65-1-JUG-CELECT-PTG34309E38350411082700234309920220322E3835041IGTCFS-65-1-JUG-CELECT-PTG34309E38350421082700234309920220322E3835042IGTCFS-65-1-JUG-CELECT-PTG34309E38355791082700234309920220325E3835579
(01)10827002343099(17)222705(10)E3857706539 of 539 codes
IGTCFS-65-1-UNI-CELECT-PTG34505E38383351082700234505520220401E3838335IGTCFS-65-1-UNI-CELECT-PTG34505E38383361082700234505520220401E3838336IGTCFS-65-1-UNI-CELECT-PTG34505E38387111082700234505520220402E3838711IGTCFS-65-1-UNI-CELECT-PTG34505E38387121082700234505520220402E3838712IGTCFS-65-1-UNI-CELECT-PTG34505E38388131082700234505520220402E3838813IGTCFS-65-1-UNI-CELECT-PTG34505E38388141082700234505520220402E3838814IGTCFS-65-1-UNI-CELECT-PTG34505E38388931082700234505520220402E3838893IGTCFS-65-1-UNI-CELECT-PTG34505E38392131082700234505520220403E3839213IGTCFS-65-1-UNI-CELECT-PTG34505E38392141082700234505520220403E3839214IGTCFS-65-1-UNI-CELECT-PTG34505E38393721082700234505520220403E3839372IGTCFS-65-1-UNI-CELECT-PTG34505E38393731082700234505520220403E3839373IGTCFS-65-1-UNI-CELECT-PTG34505E38399881082700234505520220404E3839988IGTCFS-65-1-UNI-CELECT-PTG34505E38399891082700234505520220404E3839989IGTCFS-65-1-UNI-CELECT-PTG34505E38401361082700234505520220404E3840136IGTCFS-65-1-UNI-CELECT-PTG34505E38401921082700234505520220404E3840192
(01)10827002345055(17)220406(10)E386041595 of 95 codes
IGTCFS-65-1-JUG-CELECT-PTG34309E38479171082700234309920220501E3847917IGTCFS-65-1-JUG-CELECT-PTG34309E38479181082700234309920220501E3847918IGTCFS-65-1-JUG-CELECT-PTG34309E38486661082700234309920220502E3848666IGTCFS-65-1-JUG-CELECT-PTG34309E38486671082700234309920220502E3848667IGTCFS-65-1-JUG-CELECT-PTG34309E38491511082700234309920220503E3849151IGTCFS-65-1-JUG-CELECT-PTG34309E38491521082700234309920220503E3849152IGTCFS-65-1-JUG-CELECT-PTG34309E38495601082700234309920220506E3849560IGTCFS-65-1-JUG-CELECT-PTG34309E38497001082700234309920220506E3849700IGTCFS-65-1-JUG-CELECT-PTG34309E38503361082700234309920220507E3850336IGTCFS-65-1-JUG-CELECT-PTG34309E38509711082700234309920220508E3850971IGTCFS-65-1-JUG-CELECT-PTG34309E38509851082700234309920220508E3850985IGTCFS-65-1-JUG-CELECT-PTG34309E38509861082700234309920220508E3850986IGTCFS-65-1-JUG-CELECT-PTG34309E38518921082700234309920220510E3851892IGTCFS-65-1-JUG-CELECT-PTG34309E38564491082700234309920220523E3856449IGTCFS-65-1-JUG-CELECT-PTG34309E38564511082700234309920220523E3856451
(01)10827002343099(17)222506(10)E3868341203 of 203 codes
IGTCFS-65-1-UNI-CELECT-PTG34505E38595711082700234505520220603E3859571IGTCFS-65-1-UNI-CELECT-PTG34505E38595721082700234505520220603E3859572IGTCFS-65-1-UNI-CELECT-PTG34505E38597591082700234505520220603E3859759IGTCFS-65-1-UNI-CELECT-PTG34505E38602931082700234505520220604E3860293IGTCFS-65-1-UNI-CELECT-PTG34505E38615831082700234505520220607E3861583IGTCFS-65-1-UNI-CELECT-PTG34505E38621541082700234505520220611E3862154IGTCFS-65-1-UNI-CELECT-PTG34505E38621701082700234505520220611E3862170IGTCFS-65-1-UNI-CELECT-PTG34505E38628901082700234505520220612E3862890IGTCFS-65-1-UNI-CELECT-PTG34505E38634931082700234505520220613E3863493IGTCFS-65-1-UNI-CELECT-PTG34505E38639691082700234505520220614E3863969IGTCFS-65-1-UNI-CELECT-PTG34505E38649391082700234505520220617E3864939IGTCFS-65-1-UNI-CELECT-PTG34505E38662081082700234505520220619E3866208IGTCFS-65-1-UNI-CELECT-PTG34505E38662091082700234505520220619E3866209IGTCFS-65-1-UNI-CELECT-PTG34505E38667341082700234505520220620E3866734IGTCFS-65-1-UNI-CELECT-PTG34505E38671011082700234505520220621E3867101
(01)10827002345055(17)220307(10)E387180591 of 91 codes
IGTCFS-65-1-JUG-CELECT-PTG34309E38596981082700234309920220603E3859698IGTCFS-65-1-JUG-CELECT-PTG34309E38604051082700234309920220604E3860405IGTCFS-65-1-JUG-CELECT-PTG34309E38610631082700234309920220606E3861063IGTCFS-65-1-JUG-CELECT-PTG34309E38610641082700234309920220606E3861064IGTCFS-65-1-JUG-CELECT-PTG34309E38614851082700234309920220607E3861485IGTCFS-65-1-JUG-CELECT-PTG34309E38614861082700234309920220611E3861486IGTCFS-65-1-JUG-CELECT-PTG34309E38621691082700234309920220611E3862169IGTCFS-65-1-JUG-CELECT-PTG34309E38621961082700234309920220611E3862196IGTCFS-65-1-JUG-CELECT-PTG34309E38628261082700234309920220612E3862826IGTCFS-65-1-JUG-CELECT-PTG34309E38638861082700234309920220614E3863886IGTCFS-65-1-JUG-CELECT-PTG34309E38649591082700234309920220617E3864959IGTCFS-65-1-JUG-CELECT-PTG34309E38649601082700234309920220617E3864960IGTCFS-65-1-JUG-CELECT-PTG34309E38654491082700234309920220618E3865449IGTCFS-65-1-JUG-CELECT-PTG34309E38663911082700234309920220619E3866391IGTCFS-65-1-JUG-CELECT-PTG34309E38666861082700234309920220620E3866686
IGTCFS-65-1-UNI-CELECT-PTG34505E38705871082700234505520220701E3870587IGTCFS-65-1-UNI-CELECT-PTG34505E38707051082700234505520220701E3870705IGTCFS-65-1-UNI-CELECT-PTG34505E38712431082700234505520220702E3871243IGTCFS-65-1-UNI-CELECT-PTG34505E38712441082700234505520220702E3871244IGTCFS-65-1-UNI-CELECT-PTG34505E38717431082700234505520220703E3871743IGTCFS-65-1-UNI-CELECT-PTG34505E38717441082700234505520220703E3871744IGTCFS-65-1
- 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
- Amount recalled
- 52,590 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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