Z-1957-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2019
- Initiation Date
- May 23, 2019
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 boxes (5 electrodes each)
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.
Distribution Pattern
US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
Code Information
Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024