CLINICAL LASERTHERMIA SYSTEMS AB: Medical Device Recall in 2021 - (Recall #: Z-1780-2021)

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 MR Cannula, REF: 4013-05, 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-1780-2021

Event ID: 87808

Reason for Recall:

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

Status: Terminated

Product Quantity: 40 units

Code Information:

Lot ID: 116539201117 and 116539030718 M

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