DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use...
FDA Recall #Z-0160-2026 — Class II — August 29, 2025
Product Description
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.
Reason for Recall
Wound dressing may have foreign matter on the product.
Recalling Firm
ConvaTec, Inc — Greensboro, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
80,980
Distribution
US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
Code Information
UDI-DI: 768455150922, Lot: 3L04808
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated