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U.S. Department of Health and Human Services

Class 3 Device Recall Gunther Tulip Vena Cava Filter Set

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  Class 3 Device Recall Gunther Tulip Vena Cava Filter Set see related information
Date Initiated by Firm February 25, 2019
Create Date March 19, 2019
Recall Status1 Terminated 3 on September 29, 2020
Recall Number Z-1023-2019
Recall Event ID 82226
510(K)Number K172557  
Product Classification Filter, intravascular, cardiovascular - Product Code DTK
Product Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP

Product Usage:
The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:(1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
Code Information Lots E3401464 E3401893 E3402589 E3406144 E3406883 E3408507 E3409900 E3412198 E3412763 E3413410 E3413931 E3414482 E3415815 E3415894 E3416490 E3417437 E3417944 E3419495 E3420644 E3423078 E3422549 E3424237 E3425750 E3426734 E3429970 E3433241 E3433850 E3434225 E3435234 E3435490 E3436217 E3436703 E3437435 E3438979 E3440364 E3443174 E3443485 E3444721 E3445944 E3447803 E3448635 E3449542 E3450531 E3451318 E3451991 E3452726 E3459706 E3459692 E3472210 E3473370 E3473974 E3473996 E3474508 E3474507 E3474932 E3475433 E3475752 E3476223 E3476716 E3477015 E3477504 E3478220 E3479059 E3482822 E3483889 E3485503 E3486490 E3488010 E3489743 E3490792 E3493642 E3495383 E3497756 E3499264 E3500496 E3501442 E3502173 E3502924 E3503682 E3505357 E3505995 E3506636 E3507648 E3508477 E3509616 E3511197 E3513194 E3513553 E3514576 E3514841 E3517192 E3517195 E3518920 E3522228 E3523668 E3524935 E3526731 E3527598 E3528161 E3529215 E3530605 E3532184 E3532996 E3533849 E3535499 E3535496 E3536288 E3536252 E3537863 E3539744 E3541216 E3542271 E3543848 E3545169 E3545941 E3546339 E3547069 E3547709 E3549157 E3549834 E3550508 E3551262 E3551914 E3553382 E3564483 E3566022 E3566284 E3568007 E3570158 E3570428 E3570429 E3572266 E3572670 E3575220 E3575682 E3575683 E3577284 E3577780 E3578458 E3579047 E3579046 E3579791 E3581075 E3581324 E3582314 E3583886 E3584080 E3585945 E3586421 E3587450 E3588739 E3589667 E3591259 E3593743 E3596339 E3596656 E3599332 E3601137 E3602068 E3603143 E3604737 E3607015 E3607611 E3609975 E3613665 E3615591 E3617730 E3618885 E3619797 E3620043 E3622784 E3623282 E3624216 E3624936 E3625995 E3627401 E3628044 E3629506 E3631055 E3631885 E3632554 E3634199 E3635146 E3635987 E3637817 E3639851 E3642375 E3643756 E3649667 E3650990 E3652539 E3653590 E3655199 E3657169 E3657848 E3662184 E3663755 E3667571 E3668923 E3674332 E3675436 E3676283 E3677418 E3678022 E3678445 E3679638 E3680538 E3681105 E3690817 E3692211 E3692849 E3693347 E3697665 E3698688 E3700759 E3701130 E3702552 E3704509 E3706639 E3707580 E3709390 E3710524 E3713522 E3714316 E3716704 E3717374 E3720239 E3721288 E3726132 E3727732 E3729539 E3731890 E3732666 E3733027 E3734521 E3735267 E3735629 E3738778 E3741072 E3741317 E3743075 E3757158 E3758672 E3759095 E3760785 E3761625 E3762981 E3763488 E3764235 E3764676 E3767873 E3770363 E3770897 E3771470 E3772545 E3774251 E3775515 E3777462 E3778097 E3780395 E3781522 E3783154 E3784287 E3786047 E3787309 E3787767 E3790002 E3790928 E3791544 E3792460 E3793288 E3793846 E3794806 E3795644 E3797234 E3798181 E3800731 E3802266 E3804018 E3804877 E3805675 E3808307 E3808824 E3811840 E3812856 E3817291 E3817898 
Recalling Firm/
Manufacturer		 Cook Medical Incorporated
400 N Daniels Way
Bloomington IN 47404-9155
For Additional Information Contact
812-339-2235
Manufacturer Reason
for Recall		 Updates to the Instructions for Use.
FDA Determined
Cause 2		 Labeling Change Control
Action Cook Medical sent an Urgent Medical Device Correction notification letters dated February 25, 2019 to customers. Additional customers identified later were sent letters on 3/8/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). For questions or concerns, contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Quantity in Commerce 91731 total
Distribution The products were distributed US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTK and Original Applicant = William Cook Europe ApS
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