Events

Recall of Device Recall DOSIFLOW 1 I.V. EXTENSION SET

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leventon S. A. U..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59000
  • Event Risk Class
    Class 2
  • Event Number
    Z-2601-2011
  • Event Initiated Date
    2011-03-11
  • Event Date Posted
    2011-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100804
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Controller, infusion, intravascular, electronic - Product Code LDR
  • Reason
    Leventon, s.A.U. barcelona, spain is recalling dosi-flow regulator, part number 259-0250, lot numbers 101444l and 101494l. product has potential to leak.
  • Action
    The firm, Leventon, S.A.U. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 11, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The letter instructs the customer to examine their inventory and quarantine any product subject to the recall. They were also instructed to identify their customers who have received the product, notify them of the recall, send a copy of the recall notification letter and request that the customers return any unused product. The customers were also instructed to complete and return the attached RECALL RESPONSE FORM within 5 working days via fax to 00 34 93 6532556 or e-mail to dsalvatierra@leventon.es. Questions concerning this recall should be directed to the QA Manager at 00 34 93 8176316 or e- mail to dsalvatierra@leventon.es.

Device

Device Recall DOSIFLOW 1 I.V. EXTENSION SET
  • Model / Serial
    Lot numbers: 101444L and 101494L
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: FL only.
  • Product Description
    "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON, S.A.U. C/Newton, 18-24 08635 Sant Esteve Sesrovires BARCELONA-SPAIN***Distributed by: Victus www.victus.com 4918 S.W. 74th Court Miami, FL 33155***" || To control intravascular infusion of medication.
  • Manufacturer
    Leventon S. A. U.

Manufacturer

Leventon S. A. U.
  • Manufacturer Address
    Leventon S. A. U., C/ Newton, 18-24, Sant Esteve Sesrovires, Barcelona Spain
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA