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Richard Wolf Medical Instruments Corp. recalls E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted in
Recalled July 17, 2019 · FDA recall Z-1957-2019 · Richard Wolf Medical Instruments
Hazard
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03. · FDA Class II
Units
5 boxes (5 electrodes each)
Sold at
US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
Description
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Product
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Manufacturer(s)
Richard Wolf Medical Instruments Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →