Events

Safety Alert Or Field Safety Notices for Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Teleflex.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-02-14
  • Event Date Posted
    2018-02-14
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/recall-of-specific-lots-of-rusch-sensor-series-400-silicone-and-non-sterile-rectal-pharyngeal-temperature-sensors
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by teleflex – risk of misdiagnosis and delivery of inappropriate treatment as sensors may give an inaccurate temperature reading.
  • Action
    Identify affected products listed in the manufacturer’s Field Safety Notice (FSN). Stop using the devices immediately. Follow the instructions in the manufacturer’s FSN to return affected devices.

Device

Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal ...
  • Model / Serial
  • Product Description
    Teleflex code NHS Supply Chain code GS1/UDI 179361-000120 FUS029 24026700000000 179361-000140 FUS030 24026700000000 179361-000160 FUS031 24026700000000 179361-000180 FUS032 24026700000000 179361-000180 FUS032 24026700000000 179360-000120 n/a 24026700000000 179360-000140 n/a 24026700000000 179360-000160 n/a 24026700000000 179360-000180 n/a 24026700000000 1016 n/a 24026700000000
  • Manufacturer
    Teleflex

Manufacturer

Teleflex
  • Manufacturer Address
    Teleflex UK customer service Tel: 07496 719651 Email:
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    MHRA