Events

Recall of Device Recall Anorectal Manometry 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
    34198
  • Event Risk Class
    Class 2
  • Event Number
    Z-0357-06
  • 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=43331
  • 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
    The product is mislabeled. the labeling on the front of the packaging states that product contains latex. however, the back of the package contains a latex- free symbol.
  • Action
    Consignees were notified by letter on 12/13/2005.

Device

Device Recall Anorectal Manometry Probe
  • Model / Serial
    Product model # A86-5050. All lot numbers.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.
  • Product Description
    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.
  • 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