Clinical Laserthermia Systems Ab FDA Recalls

3 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR IntrClass IIApr 1, 2021single use devices labeled as sterile may not have been adeq	single use devices labeled as sterile may not have been adequately sterilized	Class IIDevices	Apr 1, 2021
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device Class IIApr 1, 2021single use devices labeled as sterile may not have been adeq	single use devices labeled as sterile may not have been adequately sterilized	Class IIDevices	Apr 1, 2021
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product UsaClass IIApr 1, 2021single use devices labeled as sterile may not have been adeq	single use devices labeled as sterile may not have been adequately sterilized	Class IIDevices	Apr 1, 2021