Safety Information

Indications for Use

ActiGraft (RD2 System) is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC gel produced by ActiGraft is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.

Important Safety Information

ActiGraft was not verified to be compliance with other wound care products. Assure the patient monthly blood draw is below 250ml per month. Throughout the processing and application of ActiGraft System, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner as to minimize splashing, spattering, and generation of potential droplets of blood. The ActiGraft Kit includes blood-contacting components that have been sterilized by Ethylene Oxide, which may cause serious allergic reactions in patients that are sensitized. Failure to follow instructions may lead to suboptimal outcomes or product failure. Outcomes may vary.

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