Reported Mar 27, 2019 · Terminated
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The…
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
- IGTCFS-65-1-FEM-TU LIP Product UsageThe 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
- Lot codes and dates
- Lots
611 of 611 codes
E3403050E3403652E3404237E3404204E3404808E3405423E3407447E3408093E3409308E3409213E3409842E3409941E3410911E3410479E3411040E3413411E3415129E3415478E3415981E3416515E3417411E3417942E3417940E3418627E3418529E3419270E3419268E3420041E3420068E3420533E3420624E3421063E3421174E3421619E3422914E3423182E3423026E3423841E3424453E3425212E3425232E3426078E3430048E3429969E3430468E3430787E3430786E3432821E3433240E3433849E3434066E3434224E3435003E3435002E3434832E3435832E3435477E3436045E3436046E3436076
- Lots
- Amount recalled
- 91731 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Updates to the Instructions for Use.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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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