BEUDAMED
    FDA Recall Open, Classified

    CritiCore Automated Urine Output and Temperature Monitor

    Recall: Z-2243-2018 · Initiated November 10, 2017

    Recall

    Recall Number
    Z-2243-2018
    Event Number
    80085
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    EXS
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    November 10, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    CritiCore Automated Urine Output and Temperature Monitor

    Reason

    Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

    Action

    On Nov 10, 2017 Bard Medical sent notification letter to all their consignees informing them of the following: Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore MonitorAffected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or furtherdistribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to thisletter regardless of whether you have any of the affected product. Additional instructions for product return arecontained on the form. "If you have further distributed any units with the referenced serial numbers, please identify your customers and notifythem at once of this product recall: Your notification should include a copy of this letter and the accompanying enclosures. Please complete this form by 11/24/2017 and fax to 1-770-784-6469 or email a scanned copy to [email protected] . If you have affected product, please contact the BMD Customer Service via phone at 1-800-526-4455 option 5 and again option 5 or email [email protected] to obtain a Return Goods Authorization number (RGA #). Fax this form to 1-770-784-6469 or email a scanned copy to [email protected]. Attn: Recall Coordinator This recall should be carried out to the user level.

    Distribution

    AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY