Reported Mar 27, 2019 · Terminated
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product…
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 and Jugular Vein Approach, Catalog Number
- IGTCFS-65-1-UNl-TULIP Product UsageThe 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
- Lot codes and dates
- Lots
287 of 287 codes
E3401464E3401893E3402589E3406144E3406883E3408507E3409900E3412198E3412763E3413410E3413931E3414482E3415815E3415894E3416490E3417437E3417944E3419495E3420644E3423078E3422549E3424237E3425750E3426734E3429970E3433241E3433850E3434225E3435234E3435490E3436217E3436703E3437435E3438979E3440364E3443174E3443485E3444721E3445944E3447803E3448635E3449542E3450531E3451318E3451991E3452726E3459706E3459692E3472210E3473370E3473974E3473996E3474508E3474507E3474932E3475433E3475752E3476223E3476716E3477015
- 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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