Recall Z-2080-2021 ยท FRL Fiber, Medical, Absorbent
Medline Industries Inc
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 Roun
| Date | May 25, 2021 |
| Status | Terminated |
| Reason | Potential for mold contamination (Aspergillus vadensis) |
| Root cause | 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 wi |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.