FDA recall Z-0496-2022

Product

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Reason for recall

This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.

Key facts

Status

Terminated

Initiation date

2021-11-22

Report date

2022-01-19

Termination date

2023-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0496-2022