—#187957

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.

FDA product code: FRL — Fiber, Medical, Absorbent
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: LOT 5602010 Catalog numbers : CVS217106V2, CVS362443V1, CVS362120V1, CVS365244V1, RSS10009, RSS10010, MDS21468, and WRX271818

Why it was recalled

Potential for mold contamination (Aspergillus vadensis)

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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.

Timeline

Recall initiated: 2021-05-25
Terminated: 2023-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187957. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.