Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft
Summary
The FDA issued a Class II for Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large by Medline Industries Inc. Reason: Potential for mold contamination (Aspergillus vadensis).
Details
Source
Device Recall
External ID
Z-2080-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count; 2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count; 3. BEAUTY 360 Patterned Basic Cotton Rounds - multipurpose 80 count; 4. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 80 count; 5. Medline non-sterile Cotton Rounds 80 count; 6. Simply Soft Cotton Rounds - Trial Size 30 counts; 7. Simply Soft Premium Cotton Rounds 80 Count; and 8. W Textured Cotton Rounds 240 Count. For application of cleansers and astringents, and the removal of makeup and nail polish; for cleaning superficial cuts and scrapes and applying medication to the skin.
Lot/Code Info: LOT 5602010 Catalog numbers : CVS217106V2, CVS362443V1, CVS362120V1, CVS365244V1, RSS10009, RSS10010, MDS21468, and WRX271818
Quantity Affected: 214,035 cases
Reason for Recall
Potential for mold contamination (Aspergillus vadensis)
Distribution
Nationwide Distribution to states of: AL, AR, AZ, CA, CO, DC, FL, IA, IL, IN, MD, MI, MN, MO, NJ, NY, OH, PA, RI, SC, TN, TX, and VA; International to country of: Antigua.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-25
Company
Northfield, IL
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.
Medline Industries Inc has 27 FDA actions in our database, including 14 recalls and 13 clearances.
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 (Medline Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries Inc have FDA actions?
Medline Industries Inc has 27 FDA actions in our database, including 14 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2080-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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