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Z-1780-2021 Class II Terminated

Recalled by CLINICAL LASERTHERMIA SYSTEMS AB — Lund

FDA device recall Z-1780-2021 was initiated by CLINICAL LASERTHERMIA SYSTEMS AB on April 1, 2021 and is designated Class II. Reason for recall: single use devices labeled as sterile may not have been adequately sterilized The recall status is terminated (terminated August 30, 2023). Affected quantity: 40 units.

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 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.

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: 116539201117 and 116539030718 M