BEUDAMED
    FDA Recall Terminated

    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. 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-3234-2017 · Initiated June 27, 2017

    Recall

    Recall Number
    Z-3234-2017
    Event Number
    77901
    Firm
    NOVADAQ TECHNOLOGIES INC.
    FEI Number
    3012345110
    Product Code
    MMP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2017
    Terminated
    December 11, 2017
    Address
    8329 Eastlake Dr, Unit 101, Burnaby Canada

    Description

    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. 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.

    Action

    The recalling firm, Novadaq, issued an "URGENT DEVICE RECALL" letter dated 6/15/2017 via delivery by firm sales representatives or courier service (such as FedEx or UPS) on 6/27/2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to return unused product to Novadaq representative and complete and return the Acknowledgement of Receipt form by email to Novadaq Quality Department at [email protected] within 24 hours of receipt. Any questions or concerns may also be sent the listed email address. If you have any questions, please do not hesitate to contact the Director of Regulatory Affairs at 1.905.629.3822 ext 205 or email: [email protected].

    Distribution

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

    Quantity

    6 drapes