Events

Recall of Device Recall Genicon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genico, Inc., dba Genicon.

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
    50739
  • Event Risk Class
    Class 2
  • Event Number
    Z-1956-2009
  • Event Initiated Date
    2008-05-08
  • Event Date Posted
    2009-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76839
  • 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, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    Genicon is recalling the genicon disposable suction irrigation 5mm 700-005-010 and 10mm 700-005-005 tube sets. the caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the suction irrigation device.
  • Action
    All four consignees were contacted by email and fax on May 8, 2008. Wholesalers were requested to forward copies of Genicon's recall letter dated May 8, 2009 and response form to their customers. Instructions for product return was provided. Direct questions about the recall to Genicon by calling 407-657-4851 (in United States) or 0118 930 5333 (in United Kingdom).

Device

Device Recall Genicon
  • Model / Serial
    Lot Numbers: 441071225, 434071227, 434080237 and 434080373.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
  • Product Description
    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. || A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.
  • Manufacturer
    Genico, Inc., dba Genicon

Manufacturer

Genico, Inc., dba Genicon
  • Manufacturer Address
    Genico, Inc., dba Genicon, 6869 Stapoint Ct Ste 114, Winter Park FL 32792-6603
  • Manufacturer Parent Company (2017)
    Genicon Inc
  • Source
    USFDA