Events

Field Safety Notices about DuaLok Localization Wire

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Bard Peripheral Vascular, Inc.

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
    2014-09-09
  • Event Date Posted
    2014-09-25
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/09/25/vazno-obavestenje-o-povlacenju-ms-dualok-localization-wire/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Bvp received four complaints where bard dualok breast lesion localisation wires damaged packaging and the wires protruded from the packaging. … if you have already used the affected devices, it is advisable to closely monitor the patients and the medical managment should be at the discretion of the treating physician.

Device

DuaLok Localization Wire
  • Model / Serial
    item LW0037: lot REVH0625, REVJ0285, REVK0279, REWD1346, REWE1663, REWH0210, REWJ1162, REWL1233, REXC0151, REXC1597, REXJ0487, REXK2010, REYB1500, REYC1644, REYE2175, REYG0975 item:LW0057: lot REVH1110, REVJ0284, REVJ1392, REVK0821, REWA0386, REWB0291, REWB1686, REWC0831, REWD1328, REWE1476, REWF1566, REWG1788, REWG1807, REWJ1663, REWJ1664, REWK1459, REWL1432, REXB0180, REXC0152, REXC1592, REXF0126, REXF2249, REXG2346, REXH0014, REXH1180, REXJ0280, REXJ
  • Manufacturer
    Bard Peripheral Vascular, Inc

Manufacturer

Bard Peripheral Vascular, Inc