Events

Recall of Device Recall Stackhouse laser resistant suction probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microtek Medical 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
    56130
  • Event Risk Class
    Class 2
  • Event Number
    Z-2109-2010
  • Event Initiated Date
    2010-05-25
  • Event Date Posted
    2010-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92716
  • 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
    Apparatus, exhaust, surgical - Product Code FYD
  • Reason
    Product labeled as sterile was distributed without sterilization.
  • Action
    The firm notified its consignees of the problem and requested return of the product by telephone on 05/25/2010. They followed with a letter dated on 06/03/2010 re: Product Removal stating the reason for the recall and confirming the receipt of the recalled product. For further information please contact (662) 244-3220

Device

Device Recall Stackhouse laser resistant suction probe
  • Model / Serial
    Lot Number C10133
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including the states of Montana and Georgia
  • Product Description
    MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device
  • Manufacturer
    Microtek Medical Inc

Manufacturer

Microtek Medical Inc
  • Manufacturer Address
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    USFDA