Events

Recall of Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.

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
    34222
  • Event Risk Class
    Class 2
  • Event Number
    Z-0359-06
  • Event Initiated Date
    2005-12-13
  • Event Date Posted
    2006-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43297
  • 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
    Cystometric Gas (Carbon-Dioxide) On Hydraulic Device - Product Code FAP
  • Reason
    Labeling does not indicate that the product contains latex.
  • Action
    All consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter.

Device

Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.
  • Model / Serial
    All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.
  • Product Description
    Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
  • 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