Events

Safety Alert for Disposable Surgical Gown Recall

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by PAUL HARTMANN (Asia-Pacific Ltd).

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
    2012-07-23
  • Event Date Posted
    2012-07-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120723a.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: hartmann disposable surgical gown recall paul hartmann (asia-pacific ltd) has initiated a recall concerning certain lots of the hartmann foliodress gown under the following trade names:- comfort basic; comfort perfect; comfort special; protect standard; protect reinforced; protect a standard; protect a reinforced; according to paul hartmann (asia-pacific ltd), a quality inspection revealed the individual occurrence of micro-holes in a number of blisters containing sterile surgical gowns and isolation gowns. the micro-holes are unlikely to be detected through visual inspection. as a result, the sterility of affected products may be compromised. paul hartmann (asia-pacific ltd) advises users not to use the affected products any longer. product recall is on-going. according to paul hartmann (asia-pacific ltd), the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 july 2012.

Device

Disposable Surgical Gown Recall

Manufacturer

PAUL HARTMANN (Asia-Pacific Ltd)