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

FDA Recall #Z-0496-2022 — Class II — November 22, 2021

Recall #Z-0496-2022 Date: November 22, 2021 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Gentherm Medical, LLC — Blue Ash, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

484 devices

Distribution

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

Code Information

UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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