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…

Recall date

May 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1957-2019

FDA classification

Class II

Brand / firm

Richard Wolf Medical Instruments Corp.

Sold / distributed

US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.