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AUVON
Shenzhen Yuwen E-Commerce Co., Ltd. · Model SAS0403 · UDI-DI 06971292003694
10
510(k) clearances
106
Adverse events
6
Recalls
304
Facilities
Description
Medical Hydrogel Dressing is applicable to partial thickness bumns, splitting skin donor sites wound, and epidermis defects resulted from other causes, venous leg ulcers, pressure ulcers and diabetic ulcers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-02-11 | Nelson Innovaions, Llc | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2016-09-01 | CellEra LLC | Adhesive border was not sticky enough. |
| 2015-09-30 | O-Two Medical Technologies, Inc. | For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches o |
| 2006-11-09 | Embeem Inc. | Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material |
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