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Activon Manuka Honey Barrier Cream

BRIGHTWAKE LIMITED · Model CR4546 · UDI-DI 05060031484724

NEC

510(k) clearances

Adverse events (6 deaths)

Recalls

142

Facilities

Description

Activon Manuka Honey Barrier Cream is designed to act as an effective moisture barrier to aid in the prevention of Moisture-Associated Skin Damage (MASD), whilst also acting as a balm to moisturise skin and help reduce existing skin damage and irritation. • Effective moisture barrier against bodily fluids and excretions. • Contains Medical Grade Manuka Honey which assists in the prevention and treatment of infected/Inflamed skin and promotes healing. • Contains Cocoa Butter to help moisturisation of the skin and aids in the prevention of Moisture Associated Skin Damage. • Breathable to assist in the prevention of skin maceration. • Dries quickly. • Contains 99% natural ingredients. Does not contain fragrance, parabens or phthalates. • Washes out of clothing and bedding. Does not stain cotton, nylon or polypropylene.

Recalls

Date	Firm	Reason
2018-08-30	MEDLINE INDUSTRIES INC	Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
2012-06-18	Safe N Simple, LLC	The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of in
2011-05-31	BioDerm, Inc.	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male
2011-05-31	BioDerm, Inc.	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male
2011-05-31	BioDerm, Inc.	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Cl
2011-04-04	Smith & Nephew Inc.	Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SK

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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.