Z-2866-2017 Class II Terminated
FDA device recall Z-2866-2017 was initiated by Xintec Corp on June 23, 2017 and is designated Class II. Reason for recall: 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 prelimina… The recall status is terminated (terminated June 20, 2018). Affected quantity: 4343 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- June 23, 2017
- Termination Date
- June 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4343 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.
Code Information
all codes.