Events

Safety Alert Or Field Safety Notices for Various Arrow Critical Care devices

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
    2018-05-31
  • Event Date Posted
    2018-05-31
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/various-arrow-critical-care-devices-recall-due-to-incomplete-packaging-seals
  • 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 – various critical care devices manufactured from january to december 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
  • Action
    Refer to the manufacturer’s FSN for a list of affected products Identify, cease using and quarantine these devices Contact Arrow International to return the devices

Device

Various Arrow Critical Care devices
  • Model / Serial
  • Product Description
    Please refer to the FSN and related Appendix for a complete list of affected products. Note that Devices marked as non-CE marked are not on the EU market.In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex
  • Manufacturer Address
    Ken Oshanksy Arrow International Inc. 4024 Stirrup Creek Drive NC 27703 Durham USA Tel: +1 919-433-4940Email: internationalFCA@teleflex.comCliodhna Coffey UK Customer Service Fax: +44 (0) 1494 524650 Tel: +44 (0) 1494 532761Email: orders.uk@teleflex.com
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    MHRA