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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-1022-2019
Recall Event ID 82226
510(K)Number K172557  
Product Classification Filter, intravascular, cardiovascular - Product Code DTK
Product Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP

Product Usage:
The Gunther Tulip Filter implant 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 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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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