BEUDAMED
    FDA Recall Terminated

    Lactate Disposable Membrane Caps Product Number: 0018108400

    Recall: Z-0027-04 · Initiated August 28, 2003

    Recall

    Recall Number
    Z-0027-04
    Event Number
    27163
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    LNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 28, 2003
    Posted
    October 15, 2003
    Terminated
    May 23, 2012
    Address
    113 Hartwell Avenue, Lexington, MA, 02173

    Description

    Lactate Disposable Membrane Caps Product Number: 0018108400

    Reason

    Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.

    Action

    Instrumentation Laboratories notified two (2) U.S. direct customers on August 28, 2003 by telephone, regarding Lot N30601. Follow-up phoning emphasizing significance of linearity problem (and additional involved lot N307 - for 1 affected customer) performed on September 3, 2003. Phone call followed with faxback acknowledging notification and disposition of remaining product lot(s). IL service also dispatched to customer sites on September 4, 2003. International Distributor Notices sent to IL Europe and IL Mexico on September 4, 2003. Product Information Bulletins circulated on September 3, 2003, to IL personnel worldwide.

    Distribution

    IL, NY International: Italy, Mexico

    Quantity

    287 boxes