Reported Oct 24, 2012 · Terminated
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with…
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 Introducer Set. 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 NumberMOO1262250
- with lot numbers
123035371230453012318677123762811251619712526599125649321286342712868931129002821302009713075108130934641313112913364410134876471348879713489157135636821360024913629070136598721375982913767726138929161402482714119996141417541421531714218162142181631421816414268381and 14273987
- Amount recalled
- 19,716 units distributed total all products
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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