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Advazorb Silfix

BRIGHTWAKE LIMITED · Model CR4181 · UDI-DI 05060031475142

NAC

510(k) clearances

1,397

Adverse events (6 deaths)

Recalls

501

Facilities

Description

Hydrophilic foam dressing with soft silicone wound contact layer, 10cm x 20cm. Advazorb Silfix is a self adherent absorbent dressing with a Silfix® soft silicone wound contact layer. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound and provides gentle release. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The backing is breathable, prevents strike through and protects the wound.

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.