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ExuCare Wide Extension Panel

SUN SCIENTIFIC, INC. · Model EC4560 · UDI-DI 00856525007990

NAC Prescription

510(k) clearances

1,404

Adverse events (6 deaths)

Recalls

501

Facilities

Description

A wound cover wider extension panel for oversized legs that aids in the extension of the exucare which wraps around the leg which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.

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.