Lund, Sweden
CLINICAL LASERTHERMIA SYSTEMS AB recalls
1 recall recorded since 2018, most recently on 1 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 April 2021
- Terminated
- 30 August 2023
- Reason
- single use devices labeled as sterile may not have been adequately sterilized
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1781-2021, Z-1780-2021, Z-1782-2021
- 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.
- 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.
- 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 Applicato
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.