Recall Z-1545-2020 ยท OJU Skin Prep Tray
Medline Industries Inc
Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
| Date | Feb 10, 2020 |
| Status | Terminated |
| Reason | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging. |
| Root cause | Packaging |
| Action | Medline notified customers on February 18, 2020 via "Urgent Recall Immediate Action required" letter. The consignees were instructed to complete the response form and return the product. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter. |
| Quantity | 117,874 units |
| Distribution | US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.