Device product
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.
Z-2080-2021
Product summary
- Event
- Event 88129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 214,035 cases
- Official record key
device-enforcement:Z-2080-2021
Official wording
Reason: Potential for mold contamination (Aspergillus vadensis)
Code information: LOT 5602010 Catalog numbers : CVS217106V2, CVS362443V1, CVS362120V1, CVS365244V1, RSS10009, RSS10010, MDS21468, and WRX271818
Distribution pattern: 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.
Derived failure modes
-
Microbial contamination
mold contamination