BEUDAMED
    FDA Recall Terminated

    Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.

    Recall: Z-2663-2011 · Initiated March 4, 2011

    Recall

    Recall Number
    Z-2663-2011
    Event Number
    58442
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KZD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 4, 2011
    Posted
    June 24, 2011
    Terminated
    October 31, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.

    Reason

    Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.

    Action

    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 with an attached return response form to its customers via Fed Ex. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) DO NOT use infusable or InfusaScan pressure infusors (listed lot numbers). 2) Isolate all affected product and contact Vital Signs Customer Service at +1-973-956-5300 to arrange for the return and replacement of the infusor. 3) If they have forwarded any of the affected product to any other healthcare institution, forward a copy of this letter to those institutions. 4)Return only unused product. In addition, the customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions, and to complete and return the attached confirmation form via fax to +1-973-956-5440. Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

    Distribution

    Worldwide distribution: USA (nationwide) states including: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY; and countries of: Argentina, Australia, Chile, Colombia, Canada, Denmark, Dominican Republic, Finland, Germany, Greece, Hong Kong/Macao, India, Israel, Italy, Korea, Lebanon, Lativia, Mexico, Malaysia, Nicaragua, Netherlands, New Zealand, Paraguay, Philippines, Portugal Panama, Puerto Rico, Peru, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.

    Quantity

    954,888 units