Reported Mar 27, 2019 · Terminated
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C…
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?
- Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C
- ELECT-PT Product UsageThe Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the
- vena cava in the following situationsPulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and 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
923 of 923 codes
E3399953E3401784E3401785E3401913E3401911E3401914E3401912E3402467E3402464E3402465E3402466E3403044E3403041E3403042E3404603E3404602E3404601E3404600E3404797E3404803E3404796E3404802E3404801E3405420E3405418E3405419E3405417E3406127E3406124E3406126E3406125E3407452E3407451E3407453E3407450E3407454E3408090E3408506E3411083E3411084E3412098E3412189E3412100E3412097E3412686E3412684E3412685E3413252E3413251E3413250E3413797E3413798E3413800E3413799E3414417E3414704E3414705E3414703E3415273E3415271
- 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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