BEUDAMED
    FDA Enforcement Class II Terminated

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    Recall: Z-3235-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3235-2017
    Event ID
    77901
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NOVADAQ TECHNOLOGIES INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 4, 2017
    Initiation Date
    June 27, 2017
    Classification Date
    September 28, 2017
    Termination Date
    December 11, 2017
    Address
    8329 Eastlake Dr Unit 101, N/A, Burnaby, N/A, N/A, Canada

    Description

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    Reason

    The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

    Code Info

    PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.

    Distribution

    Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.

    Quantity

    16/6-drape kits