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Gentherm Medical, LLC Recall 89193

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

Gentherm Medical, LLC Recall 89193 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0496-2022
Event ID89193
Event DescriptionElectri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
Quantity484 devices
Recall ReasonThis recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Device Classification20220119
Device Code InfoUDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
Center Classification Date20220113
Recall Initiation Date20211122
Recalling FirmGentherm Medical, LLC
Initial Notification Letter
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