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FDAApril 1, 2021device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

clinical laserthermia systems abclinicalclinical laserthermia

UPCs

116540030718116540201117

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear