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Areza Medical

ADVANCED MEDICAL ASSOCIATES, LLC · Model CMC42520 · UDI-DI 00810147400546

NAC

510(k) clearances

1,440

Adverse events (6 deaths)

Recalls

501

Facilities

Description

Areza Carboxymethyl Cellulose (CMC) Gelling Fiber is a primary wound dressing made from medical-grade sodium carboxymethyl cellulose (CMC). The pad/dressing turns into a hydrophilic gel as it comes into contact with wound fluid (exudate). The newly formed gel is soft and provides an optimal moist wound healing environment, can conform to the wound bed, and by loosening the non-live material over the wound (autolytic debridement) reduces the need for physical debridement. Areza CMC gelling fiber absorbs the wound fluid in a very unique vertical direction called "vertical absorbency", a capability that may reduce the risk of maceration by reducing the horizontal spread of the wound fluid to the other parts of the dressing. This dressing is ideal for moderate to highly leaking (exuding) wounds. CMC also reduces the risk of infection by creating a physical barrier to external contaminants and microscopic organisms. The non-adhesive formed gel reduces the risk of wound trauma during dressing changes.

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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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.