Recall Z-1782-2021— CLINICAL LASERTHERMIA SYSTEMS AB

Name: FDA recall Z-1782-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-01

Class II · Terminated

Class II FDA medical device recall by CLINICAL LASERTHERMIA SYSTEMS AB, initiated 2021-04-01, terminated 2023-08-30. It names 2 FDA 510(k) clearances: K163103, K151569. Product: 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.. Reason: single use devices labeled as sterile may not have been adequately sterilized.

Recalling firm: CLINICAL LASERTHERMIA SYSTEMS AB
Classification: Class II
Status: Terminated
Initiated: 2021-04-01
Terminated: 2023-08-30
Firm location: Lund, Sweden

510(k) clearances named in this recall

2 on FDA's record

K163103 — Tranberg CLS Diffusor Laser FiberClinical Laserthermia Systems, AB·cleared 2017-03-23
K151569 — Tranberg CLS Laser FiberClinical Laserthermia Systems, AB·cleared 2016-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.