Dressings Recall: ConvaTec DuoDERM Extra Thin
FDA is recalling ConvaTec DuoDERM Extra Thin dressings due to possible foreign matter on the product. About 80,980 units were distributed nationwide in the United States, with lot 3L04808 and UDI-DI 768455150922 identified in the recall. The dressings are indicated for management of superficial, dry to lightly exudating dermal ulcers, post-operative wounds, and protective dressings.
| Brand | ConvaTec, Inc |
|---|---|
| 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. |
| Reason | Wound dressing may have foreign matter on the product. |
| Severity | moderate |
| Units affected | 617850 |
| 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. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use recalled dressings.
- Check if you have lot 3L04808 or UDI-DI 768455150922; if yes, stop using them immediately.
- Contact ConvaTec or the retailer for disposal instructions or replacement.
- If you have concerns or experienced an adverse reaction, consult your healthcare provider and report to the FDA.
How to identify the recalled item
| Lot / date codes | UDI-DI: 768455150922, Lot: 3L04808 |
|---|---|
| Lot / date codes | Lot Code: Product Name : Esteem Body" Urostomy Pouches UDI-DI: 00768455204526, 00768455204533, 00768455204540, 00768455204564, 00768455204571, 00768455204588, 00768455204595, 00768455204618, 00768455204625, 00768455204632, 00768455204649, 00768455204656, 00768455204663, 00768455204670, 00768455204700, 00768455204717, 00768455204724, 00768455204748, 00768455204755, 00768455204762 Lot / Serial Numbers for US market : 5H0475, 5J00257, 5J00475, 5J02234, 5J02340, 5J02361, 5J02732, 5K00013, 5K00338, 5K00713, 5K00338, 5K00713, 5K01320, 5K01500, 5K01541, 5K02079, 5K02104, 5K03003, 5K03008, 5L00231, 5L00444, 5L01041, 5L01042, 5L01162, 5L01935, 5L04677, 5L04679, 6A00067, 6A00218, 6A00219, 6¿01521, 6A01717 and 6A01964 Lot / Serial Numbers for global : 5J00020 , 5H04775 , 5J00257 , 5J00475 , 5J00476 , 5J00904 , 5J01425 , 5J01426 , 5J01512 , 5J01903 , 5J02218 , 5J02235 , 5J02340 , 5J02234 , 5J00903 , 5J02361 , 5J02362 , 5J01970 , 5J02732 , 5J04994 , 5J04995 , 5J05281 , 5K00712 , 5K00013 , 5K01500 , 5K01541 , 5K02080 , 5J05497 , 5K01320 , 5K02079 , 5K03003 , 5K00012 , 5K03008 , 5K01321 , 5K00338 , 5K03004 , 5K00713 , 5K02104 , 5K02095 , 5K06011 , 5K06313 , 5L00050 , 5L00231 , 5L00444 , 5K06686 , 5L00445 , 5L00691 , 5L01041 , 5L01042 , 5L01162 , 5L01508 , 5L01935 , 5L02306 , 5L02524 , 5L02796 , 5L03300 , 5L00948 , 5L04679 , 5L04677 , 5L05414 , 5L05415 , 6A00216 , 6A00217 , 6A00219 , 6A01188 , 6A00218 , 6A01717 , 6A01189 , 6A01521 , 6A00067 , 6A01522 , 6A01962 , 6A01964 , 6A01967 , 6A01965 , 6A01966 , 6A01963 , 6A02696 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.