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H&H

TRONJEN MEDICAL TECHNOLOGY INC. · Model WG0030 · UDI-DI 04719884331402

NAE

510(k) clearances

105

Adverse events

Recalls

304

Facilities

Description

"H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials.

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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Data 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.