BEUDAMED
    FDA Recall 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 · Initiated July 19, 2013

    Recall

    Recall Number
    Z-1995-2013
    Event Number
    65834
    Firm
    Blue Belt Technologies MN
    FEI Number
    3010266064
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 19, 2013
    Posted
    August 21, 2013
    Terminated
    November 14, 2013
    Address
    2905 Northwest Blvd, Ste 40, Plymouth, MN, 55441-2673

    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

    Action

    Blue Belt Technologies contacted consignees by telephone using a script on July 19, 2013. The consignees were informed of the problem and the product involved in the recall. Consignees were advised to immediate stop using the product and to locate and quarantine all unused product. Additionally, an "Urgent Medical Device Recall" letter dated July 24, 2013 was issued on July 24, 2013 and August 12, 2013. The letter includes the description of the Issue, description of safety concerns, affected product, and action to be taken by user. For questions contact Blue Belt Technologies, Lindsey Bring (+1 763.452.4922) or Robin Gonzalez (+1 763.452.4910) and get a Return Authorization number. Lindsey or Robin will arrange a pickup of the product. BBT will send replacement product at no charge.

    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.