Home / Recalls / Medical Devices
CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device
Recalled June 9, 2021 · FDA recall Z-1780-2021 · CLINICAL LASERTHERMIA SYSTEMS AB
Hazard
single use devices labeled as sterile may not have been adequately sterilized · FDA Class II
Units
40 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
Description
single use devices labeled as sterile may not have been adequately sterilized
Product
Tranberg MR Cannula, REF: 4013-05, 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.
Manufacturer(s)
CLINICAL LASERTHERMIA SYSTEMS AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →