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U.S. Department of Health and Human Services

Class 2 Device Recall Cotton Rounds/Pads

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  Class 2 Device Recall Cotton Rounds/Pads see related information
Date Initiated by Firm May 25, 2021
Create Date July 16, 2021
Recall Status1 Terminated 3 on February 27, 2023
Recall Number Z-2080-2021
Recall Event ID 88129
Product Classification Fiber, medical, absorbent - Product Code FRL
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.
Code Information LOT 5602010 Catalog numbers : CVS217106V2, CVS362443V1, CVS362120V1, CVS365244V1, RSS10009, RSS10010, MDS21468, and WRX271818
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Benjamin Gora
866-359-1704
Manufacturer Reason
for Recall		 Potential for mold contamination (Aspergillus vadensis)
FDA Determined
Cause 2		 Process control
Action On June 4, 2021 the firm sent "URGENT RECALL NOTIFICATION" letters to their consignees with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot number listed. Destroy all affected product 2. Please return the completed enclosed URGENT REMEDIAL ACTION RESPONSE FORM listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form via email to recalls@medline.com or fax to: 866-767-1290. When we receive your completed destruction form your account will receive credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704.
Quantity in Commerce 214,035 cases
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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