BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.

    Recall: Z-1459-2017 · Initiated February 20, 2017

    Recall

    Recall Number
    Z-1459-2017
    Event Number
    76458
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 20, 2017
    Posted
    March 14, 2017
    Terminated
    June 1, 2017
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.

    Reason

    Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

    Action

    Terumo CVS initiated a voluntary recall by issuing a safety advisory for their Terumo Advanced Perfusion System 1-Level Sensor II Pads, and Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. Customers are asked to do the following: 1. Review the Safety Advisory. 2. Assure that all users receive notice of this issue. 3. Confirm receipt of this Safety Advisory by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. For questions contact Terumo CVS at 1-800-521-2818, Monday Friday, 8 a.m. 6 p.m. ET. Any adverse events experienced with the use of this product, and/or quality problems should also be reported to the FDAs MedWatch Program: Phone: 1.800.FDA.1088 Fax: 1.800.FDA.0178, Web: www.fda.gov/medwatch/report.htm MedWatch Online Voluntary Reporting Form (mail to address on form): www.fda.gov/Safety/MedWatch/HowtoReport

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of: Mexico, AUSTRALIA, UNITED ARAB EMIRATES (UAE), Indonesia, Singapore, Taiwan, Thailand, COLOMBIA, CHILE, Vietnam, India, China, Malaysia, BELGIUM, Japan, CANADA

    Quantity

    3,794