CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Us…

Recall date

April 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1782-2021

FDA classification

Class II

Brand / firm

CLINICAL LASERTHERMIA SYSTEMS AB

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

Why it was recalled

single use devices labeled as sterile may not have been adequately sterilized

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.