Events

Recall of Device Recall Dry Reference pH 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
    25364
  • Event Risk Class
    Class 3
  • Event Number
    Z-0466-03
  • Event Initiated Date
    2003-01-08
  • Event Date Posted
    2003-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25666
  • 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
    Failure of the dry silver chloride reference, resulting in malfunction and a 'lead off' indication.
  • Action
    All consignees were notified by letter on 01/08/2003.

Device

Device Recall Dry Reference pH Probe.
  • Model / Serial
    All product models: C2NS, C2NS-P, C2NS-A, C2N5, C2N10, C2N15, C2N10-V, C2IS, C2I5, C2I10, C2I15, C2I10-V. All lot numbers: U02314 through U021216N-15G.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain.
  • Product Description
    ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
  • Manufacturer
    Sandhill Scientific, Inc

Manufacturer

Sandhill Scientific, Inc
  • Manufacturer Address
    Sandhill Scientific, Inc, 9150 Commerce Center Circle, #500, Highlands Ranch CO 80129
  • Source
    USFDA