Events

Safety Alert Or Field Safety Notices for Safety blood collection and infusion sets

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 Greiner Bio-One.

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/2013/047
  • Event Number
    CON287019
  • Date
    2013-06-27
  • Event Date Posted
    2013-06-27
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON287019?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 leakage of blood or infusion fluid, or under-filling of evacuated blood collection tubes or blood culture bottles. this product is being recalled due to potential cracking of the luer connector on these devices.
  • Action
    Identify and quarantine affected products. Greiner Bio-One issued a Field Safety Notice (FSN) in March 2013 recalling affected products. Confirm receipt of the FSN to Greiner Bio-One and arrange for the return and replacement of unused affected devices.

Device

Safety blood collection and infusion sets
  • Model / Serial
  • Product Description
    Safety blood collection and infusion sets. Various item and lot numbers. The affected devices are illustrated below.  The area where the crack may occur is circled.  A list of the affected item codes and lot numbers are provided in the FSN .  The NHS Supply Chain codes (England only) corresponding to the manufacturer’s item codes are given as below. Safety infusion sets Greiner Bio-One code NHS supply chain code LOT numbers 450092 KFK 024 12H23 Safety blood collection sets with Luer adapter Greiner Bio-One code NHS supply chain code LOT numbers 450081 KFK 134 12H23, 12H24, 12I17, 12I26, 12H30 450082 KFK 136 12H21, 12H22, 12H30 450083 none 12I16 450084 none 12H29 450095 KFK 302 12H19, 12I22 450099 none 12H26 Safety blood collection sets with Luer adapter and holder Greiner Bio-One code NHS supply chain code LOT Numbers 450086 KFK 138 12H28, 12H25, 12H27, 12I26, 12I24, 12I25 Safety blood collection sets with blood culture holder Greiner Bio-One code NHS supply chain code LOT Numbers 450182 KFK 416 12H21, 12H30, 450184 KFK 418 12H22, 12H23, 450185 KFK 419 12H24, 12H23, 12I20
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One