Events

Safety Alert for ProLift S 222 Standsupport Slings

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

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
    2013-12-24
  • Event Date Posted
    2013-12-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131224a.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: novacare prolift s 222 standsupport slings the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning prolift s 222 standsupport slings, manufactured by novacare. details of affected products are as follows: model no.: sizes s, m and l lot no.: all production date: september 2012 according to the manufacturer, the internal quality control system has found a problem with slings produced for the prolift s222 sit-to-stand hoist as from september 2012. some slings have not been correctly sewn. the strap which holds the buckle for the back support could tear under load. this could lead to the patient falling backwards out of the hoist and therefore a high security risk exists. the manufacturer advises customers to check the production date on the sewn on label. all slings will be inspected by the manufacturer’s quality control department and either revised or replaced and then returned to customers. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483 if you are in possession of the product, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

ProLift S 222 Standsupport Slings
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Novacare ProLift S 222 Standsupport Slings
  • Manufacturer
    Novacare

Manufacturer

Novacare
  • Source
    DH