FDA recall Z-2495-2021

Ad-Tech Medical Instrument Corporation · Class II · device

Product

Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

Reason for recall

Incorrect version of labels were used.

Distribution

Worldwide distribution - US Nationwide distribution in the states of DC, FL, MI, NY, PA and TX and the countries of Spain, France, Italy, Greece, Great Britain and Canada.

Key facts

Status
Terminated
Initiation date
2021-08-09
Report date
2021-09-29
Termination date
2023-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oak Creek, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2495-2021