—#180037

Product

Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

FDA product code: OJU — Skin Prep Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: REF DYND70288 2/PK Expiration 06/30/2022

Why it was recalled

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 (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-02-10
Terminated: 2023-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180037. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.