Summary
The FDA issued a Class II for Thermalon Eye Compress, Item Number 2434 by Bruder Healthcare Company, LLC. Reason: Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and.
Details
Source
Device Recall
External ID
Z-1359-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
Thermalon Eye Compress, Item Number 2434
Lot/Code Info: UPC 041533243427, Lot Codes: M056410
Quantity Affected: 2400 units
Reason for Recall
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-21
Company
Alpharetta, GA
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 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bruder Healthcare Company, LLC has 9 FDA actions in our database, including 9 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 (Bruder Healthcare Company, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bruder Healthcare Company, LLC have FDA actions?
Bruder Healthcare Company, LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1359-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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