Events

Safety Alert for Endo-Scrub 2 Sheaths & Tubing Set

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

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
    2014-03-13
  • Event Date Posted
    2014-03-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140313.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: medtronic endo-scrub 2 sheaths & tubing set medical device manufacturer, medtronic, has issued a field safety notice concerning certain lots of endo-scrub 2 sheaths and tubing set. the affected model numbers are as follows: sheath (with tubing): 1912000, 1912002, 1912004, 1912008, 1912023, 1912024, 1912032, 1912033, 1912038, 1912040, 1912040 tubing: 1912030 the luer connector on the end of the tubing that attaches to the sheath may break off, either prior to or during use. once the connector breaks, the flow of saline to the sheath either ceases or is reduced and leakage occurs at the fracture site. the manufacturer advises users to continue using the affected sheaths in stock, and not to scrap or return current endo-scrub sheaths. furthermore, the manufacturer will provide users with new tubing to have available and to use if users experience a broken luer connector. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 13 march 2014.

Device

Endo-Scrub 2 Sheaths & Tubing Set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Endo-Scrub 2 Sheaths & Tubing Set
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH