BEUDAMED
    FDA Recall Terminated

    Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    Recall: Z-1365-2016 · Initiated March 8, 2016

    Recall

    Recall Number
    Z-1365-2016
    Event Number
    73528
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 8, 2016
    Terminated
    August 17, 2016
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    Reason

    ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.

    Action

    ICU Medical, Inc. sent customer notification letter dated March 8, 2016, to customers to inform them that ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. The letter informs the customers that ICU Medical will provide an updated Operator's Manual to provide clarity on the difference between Operating Range and Accuracy Range as soon as they are available. Customers are informed that the updated specifications are provided with the customer communication and to be used until the Operators Manual is provided. Customers are instructed to return the completed Medical Device Safety Communication Response form to ICU Medical via Fax (801) 264-1755 or by email at [email protected]. Customers with any questions or require assistance relating to the customer notification letter are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: (866)8299025 and select option 8, or email the following address: [email protected].

    Distribution

    Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA.. Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.

    Quantity

    57 units