medical Class II Updated 2021-06-09

CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only,

Recalled Product

Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, 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

Distribution: Nationwide (United States)
Lot/Code Info: Lot ID: 116540030718, 116540201117
View official government recall

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