Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Summary
The FDA issued a Class II for Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 by Gentherm Medical, LLC. Reason: This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads..
Details
Source
Device Recall
External ID
Z-0496-2022
Action Date
2022-01-19
Status
Terminated
Category
device
Product Description
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Lot/Code Info: UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
Quantity Affected: 484 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-22
Company
Blue Ash, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 106 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Gentherm Medical, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gentherm Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gentherm Medical, LLC have FDA actions?
Gentherm Medical, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0496-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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