Reported Mar 27, 2019 · Terminated
Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-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 Jugular Vein Approach, Catalog Number
- GTCFS-65-1-JUG-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
968 of 968 codes
E3401535E3401362E3401363E3401534E3402132E3402157E3402307E3402707E3402841E3402683E3405426E3405428E3405429E3405427E3406082E3406081E3406079E3406080E3406888E3406887E3406889E3406885E3406886E3407455E3407457E3407456E3408055E3408054E3408510E3410532E3410531E3410533E3411081E3412096E3412066E3412281E3412682E3412855E3413101E3412683E3413409E3413248E3413244E3413243E3413929E3413774E3413773E3414416E3414723E3415128E3415814E3415456E3415455E3415887E3416372E3416488E3416553E3416804E3416489E3417308
- 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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