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Areza Medical

ADVANCED MEDICAL ASSOCIATES, LLC · Model CA4420 · UDI-DI 00850021481575

NAD

510(k) clearances

18,954

Adverse events (8 deaths)

Recalls

514

Facilities

Description

Calcium Alginate Wound Dressing (20) - Areza Calcium Alginate is made of natural fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering through a process of ion exchange over the wound, maintaining a moist environment for wound healing. They are soft and conformable, easy to pack, tuck or apply over irregular-shaped wounds. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Indicated for wounds with moderate to heavy exudate, such as pressure ulcers, infected wounds, and venous insufficiency ulcers. Alginates require a secondary dressing to be secured on the wound.

Recalls

Date	Firm	Reason
2025-08-29	ConvaTec, Inc	Wound dressing may have foreign matter on the product.
2025-02-19	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for the sterility of the device to be compromised.
2022-01-28	Sam Medical Products	Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov
2021-08-20	ConvaTec, Inc	Primary packaging labeling may be incorrect.
2021-08-09	ConvaTec, Inc	There is a potential for open seals which can compromise sterility.
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect

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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.