Field Safety Notices about MINISEND-LUER LOCK CAP

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Sendal S.L..

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
  • Event Number
    SN201401
  • Date
    2014-02-11
  • Event Country
  • Event Source
    HPRA
  • Event Source URL
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    A potential fault has been identified with the sealing of the primary packaging (blister) of the minisend luer lock cap, leading to a possible loss of sterility of the product. not all units are affected, only those with a small sealing surface.  the manufacturer has confirmed that devices on the irish market, with product reference codes tp-mf and tp-mf-a are affected by this action. refer to attached field safety notice (fsn).
  • Action
    Sendal S.L. requires that users check their inventory and quarantine all affected products/lots. In the absence of an alternative, it is recommended that users verify the integrity of the packaging and do not use units where the sealing appears defective.  Sendal requires that users return completed verification forms for this action to the Sendal representative.  The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.

Device

  • Model / Serial
  • Product Description
    MINISEND-LUER LOCK CAP
  • Manufacturer

Manufacturer