Xintec Corp Recalls
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OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
On October 29, 2017, the firm contacted consignees via phone. During the phone the following information was provided: 1. Convergent has become aware of an issue affecting one lot of the fibers that have been purchased recently. The affected product is the CGH1080F fibers with lot number 21144. It has been determined that the fibers in that batch were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser with it is plugged in. There have been no reports of adverse reactions related to this issue. Please return the products to Convergent. In return, we will send replacement fibers to you.
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 l
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.
The firm, Convergent Laser Technologies, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 06/23/2017 to its Consignees. The letter described the product, problem and actions to be taken. The consignees were instructed as follows: "Please immediately review your inventory and quarantine any affected product. Please return any affected products within 30 days according to the instructions provided in the attached Acknowledgement and Receipt Form. Upon receipt of the product and response form, we will arrange for a credit to your account. Also, whether or not you are returning any affected product, please send a copy of the Acknowledgement and Receipt Form to our Regulatory Department via fax at 510-832-1600 or via e-mail to regulatory@convergentlaser.com." If you have any further questions or concerns, please contact our Customer Service Department at 510-832-2130 or 800-848-8200.