Events

Recall of STAT 2 Primary Administration Set Gravity Flow Controller

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConMed Corporation.

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
    60702
  • Event Risk Class
    Class 2
  • Event Number
    Z-0632-2012
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106342
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Conmed received complaints of some units exhibiting inaccurate or inconsistent flow rates. it was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.
  • Action
    ConMed Corporation sent Urgent Medical Device Recall Letters and Response Forms dated April 14, 2011, via UPS Priority Mail pouches to all domestic consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The international consignees were sent Urgent Medical Device Recall Letters and Response Forms dated April 22, 2011, via FedEx International Priority. Users were instructed to immediately stop use of the device and return it to ConMed Corporation. --- RECALL EXPANSION: Consignees were also instructed to contact all of those organization within their facility and any other facilities that they may have supplied or given these affected products to. ConMed Corp. sent out Amended Urgent Medical Device Recall Letters and Response Forms dated May 10, 2011, to the 4 consignees via UPS PriorIty Mail for the expansion of the recall for Catalog No. S2-12N, Lot 1006234. For any questions call 315-624-3237 or email ivcontroller@conmed.com.

Device

STAT 2 Primary Administration Set Gravity Flow Controller
  • Model / Serial
    Beginning Lot Code 1006094, Ending Lot Code 1103214
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India
  • Product Description
    STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. || The STAT 2® Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA