Events

Recall of OPTILITE HOLMIUM FIBER ASSEMBLY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71305
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The reprocessing instructions may not provide sufficiently detailed information for the cleaning disinfection and sterilization of these products. our preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet current standards.

Device

OPTILITE HOLMIUM FIBER ASSEMBLY
  • Model / Serial
    Model Catalog: HLF-M940-CNV-CAN (Lot serial: all lots); Model Catalog: HLF-M550-CNV-CAN (Lot serial: all lots); Model Catalog: HLF-M365-SMA-CAN (Lot serial: all lots); Model Catalog: HLF-M365-CNV-CAN (Lot serial: all lots); Model Catalog: SMH1020F (Lot serial: all lots); Model Catalog: HLF-M273-CNV-CAN (Lot serial: all lots); Model Catalog: SMH1010F (Lot serial: all lots); Model Catalog: SMH1060F (Lot serial: all lots); Model Catalog: SMH1040F (Lot serial: all lots); Model Catalog: HLF-M273-SMA-CAN (Lot serial: all lots); Model Catalog: HLF-M940-SMA (Lot serial: all lots); Model Catalog: HLF-M940-CNV (Lot serial: all lots); Model Catalog: HLF-M550-SMA (Lot serial: all lots); Model Catalog: HLF-M273-CNV (Lot serial: all lots); Model Catalog: HLF-M365-SMA (Lot serial: all lots); Model Catalog: HLF-M365-CNV (Lot serial: all lots); Model Catalog: HLF-M273-SMA (Lot serial: all lots); Model Catalog: HLF-M550-CNV (Lot serial: all lots)
  • Product Description
    Optilite Holmium Laser Fibers;OPTILITE HOLMIUM FIBER ASSEMBLY;OPTILITE MULTI USE HOLMIUM LASER FIBERS
  • Manufacturer
    XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES

Manufacturer

XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES