FDA recall Z-1957-2019

Richard Wolf Medical Instruments Corp. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-05-23
Report date
2019-07-17
Termination date
2020-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2019