Recall Z-1957-2019— Richard Wolf Medical Instruments Corp.
Class II · Terminated
Class II FDA medical device recall by Richard Wolf Medical Instruments Corp., initiated 2019-05-23, terminated 2020-08-04. It names one FDA 510(k) clearance: K980302. 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: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03..
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-23
- Terminated
- 2020-08-04
- Firm location
- Vernon Hills, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.