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FDAMay 23, 2019device

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 co...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

What to do

FDA enforcement status: Terminated

Brands named

richard wolf medical instrumentsrichardrichard wolf

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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