Events

Safety Alert for IPM Wound Gel Rx Wound Dressing

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

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
    2014-08-07
  • Event Date Posted
    2014-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140807c.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: wellspring pharmaceutical corporation ipm wound gel rx wound dressing the united states food and drug administration (fda) has issued a medical device safety alert concerning ipm wound gel rx wound dressing with lot number 3p3446, manufactured by wellspring pharmaceutical corporation. according to the alert, there is a potential for microbial contamination of the affected product. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-2112-2014&w=08062014&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2014.

Device

IPM Wound Gel Rx Wound Dressing

Manufacturer

Wellspring Pharmaceutical Corporation