Reported Mar 27, 2019 · Terminated
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT 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?
- Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number
- IGTCFS-65-1-FEM-CELECT-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
1,187 of 1,187 codes
E3403048E3403049E3404192E3404201E3404200E3404202E3404203E3404806E3404807E3404805E3405421E3405422E3406129E3406130E3406933E3406932E3406934E3406931E3407462E3407463E3408063E3409201E3409205E3409202E3409203E3409204E3409840E3409845E3409844E3409841E3409843E3410534E3410536E3410535E3411074E3411075E3411073E3411076E3411732E3411731E3412689E3412690E3414708E3414706E3414707E3415275E3415896E3415895E3415897E3416486E3416487E3416485E3417306E3417305E3417304E3417906E3417904E3417905E3418540E3418541
- 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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