Events

Safety Alert Or Field Safety Notices for Lifeshield Primary Plumset

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 Hospira.

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
  • Event ID
    MDA/2013/081R
  • Event Number
    CON346681
  • Date
    2013-12-05
  • Event Date Posted
    2013-12-05
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON346681?tabName=allTabs
  • 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
    Risk of embolism and allergic reaction due to exposure to particulates and non-biocompatible materials, especially during administration of parenteral lipids. due to a manufacturing fault, these devices may be fitted with an incorrect filter which has not undergone biocompatibility testing. hospira issued a field safety notice (fsn) dated 22 october 2013, but has not received confirmation from enough users that they have received and acted on this information.
  • Action
    Identify, quarantine and do not use affected product lots. Use alternatives until new product is available from Hospira. Liaise with Hospira for the collection of affected product. Complete and return the reply form to Hospira. Report any adverse incidents to Hospira and the MHRA.

Device

Lifeshield Primary Plumset
  • Model / Serial
  • Product Description
    Intravenous pump set: Lifeshield Primary Plumset. Specific list numbers and lot numbers are affected. List number Lot numbers Set description 14000-92-28 27112-5H 30079-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Prepierced Y-site, 272 cm 14001-92-38* 28187-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Clave port, Clave Y-site, 272 cm *the equivalent NHS Supply Chain code for this list number is FSB1314 (England only). NHS Supply Chain has sent its own customer notice about this recall (reference NHS SC 32).
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA