BEUDAMED
    FDA Recall Terminated

    "***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.

    Recall: Z-2601-2011 · Initiated March 11, 2011

    Recall

    Recall Number
    Z-2601-2011
    Event Number
    59000
    Firm
    Leventon S. A. U. C/ Newton, 18-24 Sant Esteve Sesrovires Barcelona Spain
    FEI Number
    3002807471
    Product Code
    LDR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 11, 2011
    Posted
    June 21, 2011
    Terminated
    June 28, 2011

    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.

    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 [email protected]. Questions concerning this recall should be directed to the QA Manager at 00 34 93 8176316 or e- mail to [email protected].

    Distribution

    Nationwide Distribution: FL only.

    Quantity

    1000 cases (50,000 units)