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The RF Denervation probe is used for radiofrequency lesion procedures for the relief of chronic pain by applying heat to the nerves. The product was mislabeled. The device is a non-sterile (not germ-free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death. For more information, follow the link below.
Breit Drescher & Imprevento, P.C.
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999 Waterside Drive
Norfolk, VA 23510
Phone: 757.622.6000
Fax: 757.670.3939
Toll Free: 800.807.6060
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