Summary
The FDA issued a Class II for Stimulen Collagen Moisturizing Lotion, ST9555B by Southwest Technologies Inc. Reason: Dose audit failure after sterilization process.
Details
Source
Device Recall
External ID
Z-2109-2021
Action Date
2021-07-28
Status
Ongoing
Category
device
Product Description
Stimulen Collagen Moisturizing Lotion, ST9555B
Lot/Code Info: Lot 2104007, EXP: 02/2024
Quantity Affected: 2016 units
Reason for Recall
Dose audit failure after sterilization process
Distribution
Malaysia
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-28
Company
Kansas City, MO
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 191 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 (Southwest Technologies Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Southwest Technologies Inc have FDA actions?
This is the only FDA action we have on record for Southwest Technologies Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2109-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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