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Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3
URGO MEDICAL NORTH AMERICA, LLC · Model 00301 · UDI-DI 00851383003016
4
510(k) clearances
1,397
Adverse events (6 deaths)
9
Recalls
501
Facilities
Description
Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | DeRoyal Industries Inc | Sterile wound dressing, lacks sterility assurance |
| 2025-02-19 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for the sterility of the device to be compromised. |
| 2024-10-01 | Advanced Medical Solutions Ltd. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-10-01 | Advanced Medical Solutions Ltd. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-10-01 | Advanced Medical Solutions Ltd. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-02-27 | ConvaTec, Inc | The product does not meet sterility assurance level. |
| 2024-01-23 | MEDLINE INDUSTRIES, LP - Northfield | Product failed sterility testing. |
| 2016-06-08 | Amd-Ritmed, Inc. | The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis. |
| 2004-01-19 | DeRoyal Surgical Tray | Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.