Events

Recall of Rusch® Belly Bag® Urine Collection Bag with Hip Belt; Belly Bag,1000ml B1000, Belly Bag with 24inch Drain B1000CT, Belly Bag with Sample Port B1000P#

According to Valvira - National Supervisory Authority for Welfare and Health (via FOI), this recall involved a device in Finland that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    2013-1294
  • Date
    2013-07-19
  • Event Country
    Finland
  • Event Source
    VNSAWH
  • Notes / Alerts
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 recall data from the U.S. and Finland.
  • Extra notes in the data
    Source: NCAR
  • Reason
    Device failure / feature before use - packing - sterility.

Device

Rusch® Belly Bag® Urine Collection Bag with Hip Belt; Belly Bag,1000ml B1000, Belly Bag with 24in...

Manufacturer

Teleflex Medical