Events

Safety Alert Or Field Safety Notices for Basin/bowl liner or equipment cover (drape)

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 Microtek Medical.

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/2014/034
  • Event Number
    CON448388
  • Date
    2014-08-27
  • Event Date Posted
    2014-08-27
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON448388?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
    The manufacturer has found that some of these devices within the above product codes may have small cracks or holes. this could compromise the sterile field. the manufacturer issued a field safety notice (fsn) dated 14 july 2014 but hasn’t had enough confirmation that customers have received and acted on it.
  • Action
    Identify affected devices as described in the FSN. Remove and quarantine any affected stock and return to Microtek Medical. Complete the response form and return it to Microtek Medical.

Device

Basin/bowl liner or equipment cover (drape)
  • Model / Serial
  • Product Description
    Basin/bowl liner or equipment cover (drape). Product codes: 17700, 16700A, 3109N, 3109NT, 3108N, 33099, 9386001, 3309N, TP1909A, TP1909B. All lot numbers. These products (a type of surgical drape) are manufactured by Microtek Medical, but may be distributed by other companies. These devices will have been supplied in procedure packs. See page 5 of the manufacturer’s FSN for full product descriptions. All devices manufactured since August 2009 are affected by this recall.
  • Manufacturer
    Microtek Medical

Manufacturer

Microtek Medical