Reported Oct 24, 2012 · Terminated
Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
- Lot codes and dates
- Material Catalog NumberMOO1262230
- with lot numbers
1229347312580337126391461263918112642715126477521265193112653869126565871266302812663626126671291266778712741165127605651279935212825090128493851286081112895401129678721300291813058416130964591312066813166239132352391330947713383272133995031341841513463515134989361354573213559348136656651377500813805295138223581387266713902427140762981411977614131133141698851420693614279112and 14288333
- Material Catalog NumberMOO1262240
- with lot numbers
68 of 68 codes
123411981234178112348901123517841253346012533461125334661253346712533468126008491264271612651932126636271266362812663629126677881267403612674312127411661277157712805833128058351286081212876589129371491295390412982469130200961304807513075112131173301316961913230606132472081325441813278009132991171330931713352191133840751341501413476371134807671354555713592399136050181361085113677260137273871377500713798432138135801382235713837691138738781387521313883193138831961393654413940480
- Amount recalled
- 19,716 units distributed total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
This product could cause temporary or reversible health problems — stop using it.
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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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