Home / Recalls / CLINICAL LASERTHERMIA SYSTEMS AB / Z-1781-2021

Z-1781-2021 Class II Terminated

Recalled by CLINICAL LASERTHERMIA SYSTEMS AB — Lund

Recall Details

Product Type
Devices
Report Date
June 9, 2021
Initiation Date
April 1, 2021
Termination Date
August 30, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot ID: 116540030718, 116540201117

Other recalls by CLINICAL LASERTHERMIA SYSTEMS AB

  • Z-1782-2021 Class II — Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 40 (April 1, 2021)
  • Z-1780-2021 Class II — Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used wit (April 1, 2021)