Events

Recall of Device Recall Olympus Fluid Aspiration Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Northgate 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
    59656
  • Event Risk Class
    Class 2
  • Event Number
    Z-3179-2011
  • Event Initiated Date
    2011-07-25
  • Event Date Posted
    2011-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103229
  • 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
    Evacuator, gastro-urology - Product Code KQT
  • Reason
    The red tag was assembled to the wrong end of the silicone tubing. the red tag indicates how the fluid aspiration tubing set is loaded into the olympus sp-2 fluid irrigation and aspiration pump.
  • Action
    The firm, Northgate Technologies, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated August 18, 2011 to the Olympus America customers who ordered the Aspiration Tubing Set, 72-00114-0. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall for subsequent return to Northgate Technologies; if they further distributed this product, they were to identify and notify their customers of the recall, and complete and return the enclosed Return Response Form via fax to (847) 608-9405 or mail to: Northgate Technologies Inc., 1591 Scottsdale Court, Elgin, IL 60123. If you have any questions, please call (224) 856-2222 or e-mail to: ckurek@northgate-tech.com.

Device

Device Recall Olympus Fluid Aspiration Set
  • Model / Serial
    catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
  • Product Description
    Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 || The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
  • Manufacturer
    Northgate Technologies, Inc.

Manufacturer

Northgate Technologies, Inc.
  • Manufacturer Address
    Northgate Technologies, Inc., 1591 Scottsdale Court, Elgin IL 60123-9340
  • Manufacturer Parent Company (2017)
    Trudell Medical Limited
  • Source
    USFDA