IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older. The RECELL® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous Regenerative Epidermal Suspension (RES™) for direct application to acute partial-thickness thermal burn wounds or application in combination with meshed autografting for acute full-thickness thermal burn wounds.
CONTRAINDICATIONS: RECELL® is contraindicated for the treatment of wounds
clinically diagnosed as infected or with necrotic tissue present in the wound bed. RECELL® is contraindicated for the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate solution (Hartmann’s Solution). The skin sample collection procedure specified for use of RECELL® should not be used with patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.
WARNINGS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL® is provided sterile and is intended for single-use. Do not use RECELL® or device components if packaging is damaged, there are signs of tampering or date of use is beyond the stated expiration date. Choose a skin sample donor site that shows no evidence of surrounding cellulitis or infection. The skin sample should be processed immediately after harvesting. If a skin sample is harvested and processed according to these instructions, it should require between 15 and 30 minutes of contact with the Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and manufactured under strict controls to minimize risk of contamination, freedom from infectious agents cannot be guaranteed.
PRECAUTIONS: RECELL® is not intended to be used alone (i.e., without meshed autograft) for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL® used alone (i.e., without meshed autograft) have not been established for treatment of partial-thickness burn wounds: on the hands and articulated joints, >320 cm2, in patients with wounds totaling >20% Total Body Surface Area (TBSA). The safety and effectiveness of RECELL® plus autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, in patients with wounds totaling >50% Total Body Surface Area (TBSA).
SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL® have not been established for treatment of acute thermal partial-thickness or full-thickness burn wounds in pediatric patients younger than 18 years of age.
For complete Important Risk Information, refer to Instructions For Use.