FDA recall Z-2629-2017

Product

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

Reason for recall

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-04-19

Report date

2017-07-05

Termination date

2018-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2629-2017