Events

Safety Alert for TLC Retractor Self-Retaining Retractor System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-04-01
  • Event Date Posted
    2016-04-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160401a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific tlc retractor self-retaining retractor system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its tlc retractor self-retaining retractor system. boston scientific, as the distributor of the tlc retractor self-retaining retractor system, is implementing this medical device recall at the request of abeon medical corporation, the manufacturer and owner of these devices. boston scientific has been notified by abeon medical corporation that certain lots of their products may contain open sterile pouch seals. in reported customer complaints, the pouch opening was obvious and discovered prior to use of the device. no injuries associated with open pouches have been reported. according to abeon’s health risk assessment, the use of the device with an open pouch could result in a possible post-operative infection. further distribution or use of any product affected by this removal should cease immediately. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 april 2016.

Device

TLC Retractor Self-Retaining Retractor System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific TLC Retractor Self-Retaining Retractor System
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH