Indications for use:
The RECELL Autologous Cell Harvesting Device is indicated for repigmentation of stable depigmented vitiligo lesions in patients 18 years of age and older. The RECELL Device is intended for use by an appropriately licensed and trained healthcare professional at the patient’s point-of-care for the safe and rapid preparation of Spray-On Skin Cells from a small sample of a patient’s own skin. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site.
CONTRADICTIONS:
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. RECELL is provided to the healthcare professional sterile and is intended for single use. Do not reuse, freeze, or re-sterilize device components. Handle using aseptic technique. Do not use RECELL or device components if packaging is damaged or there are signs of tampering. Do not use RECELL or device components beyond the stated expiration date indicated on the adhesive Lot # and Expiration Date labels on the outer box packaging. Choose a healthy skin sample donor site that shows no evidence of lack of pigmentation or surrounding cellulitis or infection. For optimum cell viability, the skin sample should be processed immediately after harvesting. Do not use silver sulfadiazine or other cytotoxic agents on the ablative laser prepared RECELL treatment areas. 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. The Enzyme is derived from animal tissue and, although strict controls have been implemented in the manufacturing process to minimize the risk of pathogen contamination, a small risk of contamination exists and absolute freedom from infectious agents cannot be guaranteed. Contaminated materials and waste must be disposed of using appropriate biohazard waste receptacles.
PRECAUTIONS:
The safety and effectiveness of RECELL has not been established for repigmentation of: vitiligo lesions appearing on lips, eyelids, plantar surface of feet, or palmar surface of hands; vitiligo lesions with recent history (within 12 months) of Koebnerization, confetti-like or trichrome appearance; and patients with a history of keloid formation.
INSTRUCTIONS FOR USE:
Consult the Instructions for Use prior to using RECELL. For complete Important Safety Information, refer to Instructions for Use.
