BEUDAMED
    FDA Recall Terminated

    Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.

    Recall: Z-2008-2009 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-2008-2009
    Event Number
    52209
    Firm
    Enginivity LLC
    FEI Number
    3006095475
    Product Code
    LGZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2009
    Posted
    September 4, 2009
    Terminated
    May 2, 2012
    Address
    1 Militia Drive, LL A, Lexington, MA, 02421

    Description

    Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.

    Reason

    1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring).

    Action

    Vital Signs, Inc. issued Product Safety Notification on March 23, 2009 informing users of potential EMI and fluid ingress issues. All warmers in the field will be replaced beginning in May 2009.

    Distribution

    Worldwide Distribution -- USA, Philippines, Saudi Arabia, India, Israel, Australia, Mexico, Germany, Republic of Singapore, China, Guatemala, Switzerland, Dubai United Arab Emirates, New Zealand, Malaysia, India, Ecuador, & United Kingdom.

    Quantity

    3052 units