Vernon Hills, IL, United States
Richard Wolf Medical Instruments Corp. recalls
1 recall recorded since 2018, most recently on 23 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 23 May 2019
- Terminated
- 4 August 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1957-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.