Events

Safety Alert Or Field Safety Notices for Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors

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 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/2014/042
  • Event Number
    CON471141
  • Date
    2014-11-03
  • Event Date Posted
    2014-11-03
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON471141?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 packaging of these devices might not be sealed properly. however, the adaptors are used as part of a non-sterile system, so there is minimal risk of infection to patients. teleflex sent an amended field safety notice (dated 19 september 2014) to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information.
  • Action
    Identify and quarantine the affected devices using the codes in the FSN. Return affected devices and arrange for replacements from Teleflex. Return the acknowledgement form to the manufacturer.

Device

Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors
  • Model / Serial
  • Product Description
    Hudson RCI © nebulizer adaptors and Aquapak sterile water with nebulizer adaptors. Specific product and lot numbers. Check Appendix 2 of the FSN for the full list of affected product codes. If relevant to you, the national supply codes are as follows: England NPC: NHS Supply chain code Manufacturer’s part number Product description FDE115 4044-28 AQUAPAK 428 SW,440 ML W/028 ADAPTOR,INTL FDE130 403128 ADAPTOR,028 NEB,INTL FDE369 403728 AQUAPAK 728 SW,760 ML W/028 ADAPTOR,INTL FDE384 404128 AQUAPAK 1028 SW,1070 ML W/028 ADAPTOR,IN Northern Ireland: The products identified in the FSN are not on regional contract within Northern Ireland but may have been acquired as non-stock items. Scotland SKU: Supply chain code Manufacturer’s part number Product description 031498 403128 ADAPTOR, 028 NEB, INTL
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical