BEUDAMED
    FDA Recall Terminated

    STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body.

    Recall: Z-0629-2012 · Initiated April 15, 2011

    Recall

    Recall Number
    Z-0629-2012
    Event Number
    60702
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    LDR
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 15, 2011
    Posted
    January 11, 2012
    Terminated
    January 15, 2013
    Address
    525 French Road, Utica, NY, 13502

    Description

    STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body.

    Reason

    ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.

    Action

    ConMed Corporation sent Urgent Medical Device Recall Letters and Response Forms dated April 14, 2011, via UPS Priority Mail pouches to all domestic consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The international consignees were sent Urgent Medical Device Recall Letters and Response Forms dated April 22, 2011, via FedEx International Priority. Users were instructed to immediately stop use of the device and return it to ConMed Corporation. --- RECALL EXPANSION: Consignees were also instructed to contact all of those organization within their facility and any other facilities that they may have supplied or given these affected products to. ConMed Corp. sent out Amended Urgent Medical Device Recall Letters and Response Forms dated May 10, 2011, to the 4 consignees via UPS PriorIty Mail for the expansion of the recall for Catalog No. S2-12N, Lot 1006234. For any questions call 315-624-3237 or email [email protected].

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India