Events

Safety Alert for Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells

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

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
    2014-04-23
  • Event Date Posted
    2014-04-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140423.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: baxter peritoneal dialysis transfer sets, titanium adapters, disconnect caps and clamshells medical device manufacturer, baxter healthcare, has issued a field safety notice concerning its peritoneal dialysis transfer sets, titanium adapters, disconnect caps and clamshells. the concerned product codes are 5c4160, 5c4482, 5c4129, spc4213, 5c4215p and 6ac4466h. the manufacturer provides an important safety update to the instruction for use (ifu) for the concerned products. specifically, the manufacturer is adding a contraindication statement to address iodine allergy for the manufacturer’s peritoneal dialysis products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended. for patients sensitive to iodine, the use of products which contain iodine or for which iodine use is recommended could result in a contact allergy or an adverse reaction if it enters the peritoneal cavity. according to the local supplier, baxter healthcare (hong kong), the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 april 2014.

Device

Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare