Xintec Corp recalls OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVE…

Recall date

June 23, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2866-2017

FDA classification

Class II

Brand / firm

Xintec Corp

Sold / distributed

Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.

Why it was recalled

It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.