Events

Recall of Disposable Internal Reference Impedance Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sandhill Scientific, 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
    27519
  • Event Risk Class
    Class 3
  • Event Number
    Z-0104-04
  • Event Date Posted
    2003-11-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30000
  • 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
    Electrode, Ph, Stomach - Product Code FFT
  • Reason
    Pouch containing pediatric probes was labeled as containing adult probes.
  • Action
    The 3 consignees were notified by telephone on 09/24/2003, followed by a letter.

Device

Disposable Internal Reference Impedance Probe
  • Model / Serial
    Product Model ZAN S61C01E, Lot Number Z0306005
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CO, MT, TX.
  • Product Description
    ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
  • Manufacturer
    Sandhill Scientific, Inc

Manufacturer

Sandhill Scientific, Inc
  • Manufacturer Address
    Sandhill Scientific, Inc, 9150 Commerce Center Cir Ste 500, Highlands Ranch CO 80129-1563
  • Source
    USFDA