FDA recall Z-1847-2021

Product

CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract

Reason for recall

The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.

Distribution

US distribution to: CA, MD, MO, NJ, PA, and TX

Key facts

Status

Terminated

Initiation date

2021-04-30

Report date

2021-06-16

Termination date

2023-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1847-2021