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RECELL® SYSTEM OUS IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE: RECELL® is indicated for harvesting of skin cells from a patient’s split-thickness skin samples, for reintroduction to the patient. Please see the Instructions for Use for each country for specific indication use of RECELL.
CONTRAINDICATIONS: RECELL® are contraindicated for treatment of infected wounds
or with necrotic tissue present in the wound bed, and for patients having unstable vitiligo or a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidine-iodine, or chlorhexidine solutions.
WARNINGS AND PRECAUTIONS: Regenerative Epidermal Suspension (RESTM ) prepared using the RECELL® Device should only be applied to patients from whom the original skin sample was taken. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. A skin sample should require between 15 and 30 minutes contact with the Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed. RESTM should be applied to a clean, dry, haemostatic vascularized wound bed.
For complete Important Safety Information refer to Instructions For Use for specific countries.
ADVERSE REACTIONS Any adverse reaction or suspected adverse reaction related to RECELL® ReCell should immediately be reported to Avita Medical.
*In all countries outside of Europe, our portfolio is marketed under the RECELL® brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. RECELL® is TGA-registered in Australia, CFDA-cleared in China and CE-mark in Europe. In the United States, RECELL® is not approved for sale and is limited by federal law to investigational use.