Events

Recall of Storz

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karl Storz Endoscopy America 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
    44957
  • Event Risk Class
    Class 2
  • Event Number
    Z-0144-2008
  • Event Initiated Date
    2007-08-17
  • Event Date Posted
    2007-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64646
  • 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
    Fluid Management Stand - Product Code HIG
  • Reason
    Outflow difference: the accuracy of the equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.
  • Action
    All affected customers were notified via a Customer Letter issued on September 10, 2007 via FedEx overnight mail. The letter describes the problem with the device and the health hazard risk, and provides instructions for users to return the old stand and make arrangements for replacement stands.

Device

Storz
  • Model / Serial
    Product Number 26601EQ-KT (device has no lot or serial numbers)
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 600 Corporate Pointe, Culver City CA 90230-7600
  • Source
    USFDA