Summary
The FDA issued a Class II for Pink Luminous Breast, Breast transilluminator by Silkprousa LLC. Reason: Firm is marketing and distributing the Pink Luminous Breast device without premarket approval.
Details
Source
Device Recall
External ID
Z-2269-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
Pink Luminous Breast, Breast transilluminator
Lot/Code Info: Product is not lot coded, all devices are subject
Quantity Affected: 2000 devices
Reason for Recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Distribution
US Nationwide distribution in the states of WA, RI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-20
Company
Miami, FL
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 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Silkprousa LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Silkprousa LLC have FDA actions?
This is the only FDA action we have on record for Silkprousa LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2269-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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