Events

Safety Alert for Alterna® Sterile Post-Operative ostomy bags

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

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
    2011-07-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20110728.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
    Press release
  • Reason
    Recall of alterna® sterile post-operative ostomy bags due to sterility problem after assessing a notification from a local medical device supplier, coloplast (hong kong) ltd, about its proposal to recall one of its product alterna® sterile post-operative ostomy bag from consumers on sterility ground, the department of health (dh) endorsed the action. coloplast, the manufacturer of the device under recall, found during routine product sterility test that a lot has failed. investigation reveals that the failed lot of product was sterilised after january 2010, when the sterilisation process was moved over to a new site. thus, coloplast decided to conduct a recall of all products sterilised at the new site, though no report of any adverse incident arising from the use of ostomy bags produced in the new site has been received worldwide. dh also had not received any such notification locally. the models under recall are 12808, 12810 and 12818, all with expiry date on january 1, 2013 or later. alterna® sterile post-operative ostomy bag is used for collecting output from stoma - an opening created on the abdomen after bowel or urinary tract surgery in order to divert faeces or urine respectively. a spokesman for dh said, "since there is concern over the sterility of the product, with potential risk of infection, the department endorses coloplast (hong kong) ltd's recall as a measure to safeguard public health." coloplast (hong kong) ltd's sales record showed that its products have been sold to both hospitals and patients here in hong kong. "customers who have the affected products in hand should return them to coloplast (hong kong) ltd. the company can be reached through its hotline at telephone number 3628 7436. people who have used the products should also consult their healthcare professionals if feel unwell or in doubt," the spokesman advised. dh had already alerted the hospital authority, private hospitals, relevant healthcare institutions and medical associations about the matter, and will closely monitor the recall besides continuing investigation. ends/thursday, july 28, 2011 issued at hkt 20:58.

Device

Alterna® Sterile Post-Operative ostomy bags
  • Model / Serial
  • Product Description
    Press release: Recall of Alterna® Sterile Post-Operative ostomy bags due to sterility problem
  • Manufacturer
    Coloplast

Manufacturer

Coloplast