Device product
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.
Z-0160-2026
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 97445
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80,980
- Official record key
device-enforcement:Z-0160-2026
Official wording
Reason: Wound dressing may have foreign matter on the product.
Code information: UDI-DI: 768455150922, Lot: 3L04808
Distribution pattern: 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.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter