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Ducare®
Derma Sciences Canada Inc · Model 99408 · UDI-DI 00809958093528
10
510(k) clearances
271
Adverse events (6 deaths)
6
Recalls
575
Facilities
Description
4 in X 4 in, H-Fold, 8-ply, 20 x 10 mesh Gauze sponges. Non-Sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-05 | Medline Industries Inc | RevMedX Trauma Dressing is being recalled due to package seal integrity. |
| 2018-12-27 | Cardinal Health 200, LLC | Curity All Purpose Sponges were not sterilized and distributed |
| 2018-10-16 | ASO, LLC | Potential that gauze pads may not be fully sterilized |
| 2015-08-12 | Revmedx Inc | The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective m |
| 2012-05-14 | Hartmann USA, Inc | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products |
| 2012-05-14 | Hartmann USA, Inc | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products |
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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.