BEUDAMED
    FDA Enforcement Class II Terminated

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    Recall: Z-1995-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1995-2013
    Event ID
    65834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Blue Belt Technologies MN
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 28, 2013
    Initiation Date
    July 19, 2013
    Classification Date
    August 21, 2013
    Termination Date
    November 14, 2013
    Address
    2905 Northwest Blvd Ste 40, N/A, Plymouth, MN, 55441-2673, United States

    Description

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    Reason

    Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at

    Code Info

    Lot: D130432, expires February 2018

    Distribution

    Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.

    Quantity

    60 cartons (20 pieces/carton) 40 in EU, 20 in US.