Events

Field Safety Notices about Pleur-Evac

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia 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
    Field Safety Notice
  • Date
    2016-03-31
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Teleflex publishes a warning notice for its customers due to a labeling error. the tyvek bag lacks a sticker used by customers to identify the material code, batch number and deadline usability when the product is removed from the delivery box (see figure 1, appendix 2). therefore, it is not possible to clearly identify the product without breaking through the sterile packaging to access the label of each unit. except for the possible slowdown of the procedure, this error has little or no clinical impact, as the user can immediately notice it.

Device

Pleur-Evac
  • Model / Serial
    PE PNEUMONECTOMY LF 6/CS A-4301-08LF PE ADULT-PED DRY/ WET LF 6/CS A-6000-08LF PE DRY/WET DUAL COLL LF 6/CS A-6002-08LF PE INFANT DRY/WET LF 6/CS A-6020-08LF PE ADULT-PED WET LF 6/CS A-7000-08LF PE ADULT-PED WET LF 6/CS A-8000-08LF PE ADULT-PED WET DUAL COLL LF 6/CS A-8002-08LF PE MINI SAHARA 6/BX LATEX FREE S-0500 PE SAHARA ATS BAG LF 6/CS S-100-08LF PE SAHARA DRY SUCT/DRY SEAL LF 6/CS S-1100-08LF PE SAHARA DRY SUCT/DRY SEAL DUAL LF 6 S-1102-08LF
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical