CLINICAL LASERTHERMIA SYSTEMS AB: Medical Device Recall in 2021 - (Recall #: Z-1782-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, 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.

Product Classification:

Class II

Date Initiated: April 1, 2021

Date Posted: June 9, 2021

Recall Number: Z-1782-2021

Event ID: 87808

Reason for Recall:

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

Status: Terminated

Product Quantity: 90 units

Code Information:

Lot # 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00049/2020/02

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated