Events

Safety Alert for Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets

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

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
    2011-12-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111223.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
    Field safety notice: smiths medical voluntary recall for level 1® d/di-60hl normothermic iv fluid administration sets, and hotline® blood and iv fluid warming sets medical device manufacturer, smiths medical asd, inc., is conducting a product recall for the following products: a) level 1® d/di-60hl normothermic iv fluid administration sets, and b) hotline ® blood and iv fluid warming sets (product codes: l-70, l-70ni, l-80, l-270, and l-370). there was an increasing trend in reports of disconnections of the luer lock connector at the patient end of the tubing on certain sets of the above two products. based on the information provided by the manufacturer, if the luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury, or while highly unlikely, death. the manufacturer has received no reports of serious injury or death related to the problem. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the attached field safety notice (a) and field safety notice (b). if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid War...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smiths Medical Voluntary Recall for Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets
  • Manufacturer
    Smiths Medical ASD

Manufacturer

Smiths Medical ASD