BEUDAMED
    FDA Recall Terminated

    Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy

    Recall: Z-1054-04 · Initiated April 26, 2004

    Recall

    Recall Number
    Z-1054-04
    Event Number
    28921
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    NEP--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2004
    Posted
    July 20, 2004
    Terminated
    April 11, 2006
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy

    Reason

    The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted

    Action

    Baxter began telephoning their customers on 4/26/04, advising them that an improperly adjusted Vlier pin could result in an ingredient delivery outside of stated accuracy limits. The accounts were requested to immediately stop using the Micromix Compounder and return the device to Baxter, and to evaluate all TPN formualtions that have been compounded but not administered to determine if any ingredients were delivered at a programmed volume of less than 1 mL. The account was advised to discard those solutions and recompound them using manual techniques. Follow-up recall letters were faxed to the accounts on the same date, reiterating the telephone calls. Baxter sent second recall letters dated 2/16/05 to the 15 customers who had not yet returned their Micromix Compounder as of 2/16/05, along with a copy of the 4/26/04 recall letter. The customers were informed of the new issue with the Micromix Compounder not recognizing decimal points for delivery volumes below 1 mL, and were again requested to return the Micromix Compounder and the handheld keypad to Baxter so that they may be corrected when the Micromix is reintroduced the market.

    Distribution

    Nationwide and internationally through Baxter subsidiaries to the United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan and Korea.

    Quantity

    500 devices