Reported Mar 27, 2019 · Terminated
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP 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 Jugular Vein Approach, Catalog Number
- IGTCFS-65-1-JUG-TULIP 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
593 of 593 codes
E3401429E3401430E3402143E3402588E3405430E3406123E3406563E3406890E3406882E3407458E3409899E3411082E3411812E3412279E3412067E3412856E3413249E3413830E3413930E3414511E3414455E3414510E3414724E3415321E3415979E3416514E3417553E3417943E3418611E3419189E3420042E3420525E3420494E3421070E3421696E3422130E3422590E3423025E3423702E3424222E3424835E3425156E3426022E3426687E3426609E3426686E3427383E3427414E3427856E3428169E3428958E3429392E3429891E3430760E3431331E3431941E3432901E3433348E3433370E3433819
- 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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