CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Dif
Recalled Product
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Hazard / Issue
single use devices labeled as sterile may not have been adequately sterilized
Issued by
FDA
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