Events

Recall of Device Recall NOVADAQ SPYPHI

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NOVADAQ TECHNOLOGIES INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77901
  • Event Risk Class
    Class 2
  • Event Number
    Z-3236-2017
  • Event Initiated Date
    2017-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158508
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cover, barrier, protective - Product Code MMP
  • 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 quality@novadaq.com 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: jpendlebury@novadaq.com.

Device

Device Recall NOVADAQ SPYPHI
  • Model / Serial
    Lots #1703291, #1704141, and #1704101
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
  • Product Description
    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), 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.
  • Manufacturer
    NOVADAQ TECHNOLOGIES INC.

Manufacturer

NOVADAQ TECHNOLOGIES INC.
  • Manufacturer Address
    NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA