Reported Apr 13, 2022 · Terminated
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917;…
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?
- Gunther Tulip Vena Cava Filter Set for Femoral
- Vein Approach Catalog Number/GPN
IGTCFS-65-1-FEM-TULIP G52917IGTCFS-65-1-JUG-TULIP G52916IGTCFS-65-1-UNI-TULIP G52918
- Lot codes and dates
- 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(01)10827002529172(17)220306(10)E3859845
599 of 599 codes
IGTCFS-65-1-UNI-TULIPG52918E38144931082700252918920220114E3814493IGTCFS-65-1-UNI-TULIPG52918E38172911082700252918920220123E3817291IGTCFS-65-1-UNI-TULIPG52918E38178981082700252918920220125E3817898IGTCFS-65-1-UNI-TULIPG52918E38184941082700252918920220128E3818494IGTCFS-65-1-FEM-TULIPG52917E38137631082700252917220220110E3813763IGTCFS-65-1-FEM-TULIPG52917E38154761082700252917220220116E3815476IGTCFS-65-1-FEM-TULIPG52917E38154771082700252917220220116E3815477IGTCFS-65-1-FEM-TULIPG52917E38171251082700252917220220123E3817125IGTCFS-65-1-FEM-TULIPG52917E38175621082700252917220220124E3817562IGTCFS-65-1-FEM-TULIPG52917E38183601082700252917220220128E3818360IGTCFS-65-1-FEM-TULIPG52917E38183611082700252917220220128E3818361IGTCFS-65-1-FEM-TULIPG52917E38194741082700252917220220131E3819474IGTCFS-65-1-JUG-TULIPG52916E38148781082700252916520220115E3814878IGTCFS-65-1-JUG-TULIPG52916E38158331082700252916520220122E3815833IGTCFS-65-1-JUG-TULIPG52916E38158661082700252916520220122E3815866
(01)10827002529189(17)221909(10)E3899596315 of 315 codes
IGTCFS-65-1-FEM-TULIPG52917E38603951082700252917220220604E3860395IGTCFS-65-1-FEM-TULIPG52917E38615101082700252917220220607E3861510IGTCFS-65-1-FEM-TULIPG52917E38620821082700252917220220611E3862082IGTCFS-65-1-FEM-TULIPG52917E38629111082700252917220220612E3862911IGTCFS-65-1-FEM-TULIPG52917E38639531082700252917220220614E3863953IGTCFS-65-1-FEM-TULIPG52917E38655571082700252917220220618E3865557IGTCFS-65-1-FEM-TULIPG52917E38661161082700252917220220619E3866116IGTCFS-65-1-FEM-TULIPG52917E38678561082700252917220220624E3867856IGTCFS-65-1-FEM-TULIPG52917E38685001082700252917220220625E3868500IGTCFS-65-1-FEM-TULIPG52917E38689971082700252917220220626E3868997IGTCFS-65-1-FEM-TULIPG52917E38695941082700252917220220627E3869594IGTCFS-65-1-JUG-TULIPG52916E38596971082700252916520220603E3859697IGTCFS-65-1-JUG-TULIPG52916E38604061082700252916520220604E3860406IGTCFS-65-1-JUG-TULIPG52916E38604421082700252916520220604E3860442IGTCFS-65-1-JUG-TULIPG52916E38604431082700252916520220604E3860443
(01)10827002529172(17)220309(10)E3892917IGTCFS-65-1-UNI-TULIPG52918E38954811082700252918920220910E3895481IGTCFS-65-1-UNI-TULIPG52918E38971361082700252918920220913E3897136IGTCFS-65-1-UNI-TULIPG52918E38988881082700252918920220918E3898888IGTCFS-65-1-UNI-TULIPG52918E39020961082700252918920220925E3902096IGTCFS-65-1-UNI-TULIPG52918E39026751082700252918920220926E3902675IGTCFS-65-1-FEM-TULIPG52917E3892917
(01)10827002529189(17)222911(10)E3927997223 of 223 codes
IGTCFS-65-1-FEM-TULIPG52917E38929161082700252917220220903E3892916IGTCFS-65-1-FEM-TULIPG52917E38930941082700252917220220903E3893094IGTCFS-65-1-FEM-TULIPG52917E38937071082700252917220220904E3893707IGTCFS-65-1-FEM-TULIPG52917E38937281082700252917220220905E3893728IGTCFS-65-1-FEM-TULIPG52917E38977821082700252917220220916E3897782IGTCFS-65-1-FEM-TULIPG52917E38991081082700252917220220918E3899108IGTCFS-65-1-FEM-TULIPG52917E39001081082700252917220220920E3900108IGTCFS-65-1-FEM-TULIPG52917E39026741082700252917220220926E3902674IGTCFS-65-1-FEM-TULIPG52917E39037051082700252917220220927E3903705IGTCFS-65-1-FEM-TULIPG52917E39043501082700252917220220930E3904350IGTCFS-65-1-JUG-TULIPG52916E38921851082700252916520220902E3892185IGTCFS-65-1-JUG-TULIPG52916E38921861082700252916520220902E3892186IGTCFS-65-1-JUG-TULIPG52916E38923311082700252916520220902E3892331IGTCFS-65-1-JUG-TULIPG52916E38941951082700252916520220905E3894195IGTCFS-65-1-JUG-TULIPG52916E38944731082700252916520220906E3894473
(01)10827002529189(17)232001(10)E3942705287 of 287 codes
IGTCFS-65-1-UNI-TULIPG52918E39173371082700252918920221104E3917337IGTCFS-65-1-UNI-TULIPG52918E39184731082700252918920221106E3918473IGTCFS-65-1-UNI-TULIPG52918E39195131082700252918920221108E3919513IGTCFS-65-1-UNI-TULIPG52918E39206901082700252918920221112E3920690IGTCFS-65-1-UNI-TULIPG52918E39212801082700252918920221113E3921280IGTCFS-65-1-UNI-TULIPG52918E39234931082700252918920221119E3923493IGTCFS-65-1-UNI-TULIPG52918E39246271082700252918920221121E3924627IGTCFS-65-1-UNI-TULIPG52918E39261511082700252918920221126E3926151IGTCFS-65-1-UNI-TULIPG52918E39263941082700252918920221126E3926394IGTCFS-65-1-FEM-TULIPG52917E39169801082700252917220221101E3916980IGTCFS-65-1-FEM-TULIPG52917E39177571082700252917220221105E3917757IGTCFS-65-1-FEM-TULIPG52917E39184191082700252917220221106E3918419IGTCFS-65-1-FEM-TULIPG52917E39184201082700252917220221106E3918420IGTCFS-65-1-FEM-TULIPG52917E39191131082700252917220221107E3919113IGTCFS-65-1-FEM-TULIPG52917E39195121082700252917220221108E3919512
(01)10827002529165(17)231401(10)E394066167 of 67 codes
IGTCFS-65-1-UNI-TULIPG52918E39374841082700252918920230106E3937484IGTCFS-65-1-UNI-TULIPG52918E39438421082700252918920230122E3943842IGTCFS-65-1-UNI-TULIPG52918E39458571082700252918920230128E3945857IGTCFS-65-1-FEM-TULIPG52917E39370331082700252917220230103E3937033IGTCFS-65-1-FEM-TULIPG52917E39378041082700252917220230107E3937804IGTCFS-65-1-FEM-TULIPG52917E39384721082700252917220230108E3938472IGTCFS-65-1-FEM-TULIPG52917E39389061082700252917220230109E3938906IGTCFS-65-1-FEM-TULIPG52917E39422181082700252917220230117E3942218IGTCFS-65-1-FEM-TULIPG52917E39427041082700252917220230120E3942704IGTCFS-65-1-FEM-TULIPG52917E39438411082700252917220230122E3943841IGTCFS-65-1-FEM-TULIPG52917E39448261082700252917220230124E3944826IGTCFS-65-1-FEM-TULIPG52917E39458821082700252917220230128E3945882IGTCFS-65-1-FEM-TULIPG52917E39463131082700252917220230129E3946313IGTCFS-65-1-FEM-TULIPG52917E39463141082700252917220230129E3946314IGTCFS-65-1-FEM-TULIPG52917E39470371082700252917220230130E3947037
332 of 332 codes
IGTCFS-65-1-JUG-TULIPG52916E39364291082700252916520230102E3936429IGTCFS-65-1-JUG-TULIPG52916E39380191082700252916520230107E3938019IGTCFS-65-1-JUG-TULIPG52916E39384361082700252916520230108E3938436IGTCFS-65-1-JUG-TULIPG52916E39388381082700252916520230109E3938838IGTCFS-65-1-JUG-TULIPG52916E39398911082700252916520230113E3939891IGTCFS-65-1-JUG-TULIPG52916E39416571082700252916520230116E3941657IGTCFS-65-1-JUG-TULIPG52916E39422261082700252916520230117E3942226IGTCFS-65-1-JUG-TULIPG52916E39443411082700252916520230123E3944341IGTCFS-65-1-JUG-TULIPG52916E39451871082700252916520230127E3945187IGTCFS-65-1-JUG-TULIPG52916E39451881082700252916520230127E3945188IGTCFS-65-1-JUG-TULIPG52916E39458831082700252916520230128E3945883IGTCFS-65-1-JUG-TULIPG52916E39465331082700252916520230129E3946533IGTCFS-65-1-JUG-TULIPG52916E39470301082700252916520230130E3947030IGTCFS-65-1-JUG-TULIPG52916E39472391082700252916520230131E3947239IGTCFS-65-1-UNI-TULIPG52918E39478451082700252918920230203E3947845
- 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
- Amount recalled
- 24,641 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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