Events

Recall of Device Recall STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration and Extension set

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
    79129
  • Event Risk Class
    Class 2
  • Event Number
    Z-0804-2018
  • Event Initiated Date
    2017-06-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161416
  • 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
    Controller, infusion, intravascular, electronic - Product Code LDR
  • Reason
    Intravascular (i.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
  • Action
    The firm, ConMed, sent an "URGENT: DEVICE RECALL" letter dated 6/21/2017 to its domestic and foreign customers. The letter described the product, the problem and the actions to be taken. The customers were instructed NOT to use any STAT 2¿ I.V. Gravity Flow Controllers manufactured between April 27, 2012 and April 12, 2017; review your inventory for any of the devices listed on Attachment I; contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately; if you HAVE inventory of any of the devices listed, complete the Business Reply Form and return it with devices to: CONMED Corporation, 525 French Road, Utica, NY 13502 via UPS Account # W5Y243; if you DO NOT HAVE any affected devices complete and return the form by email: stat2@conmed.com; fax: Field Action Support Team at 315-624-3225 or US mail to CONMED Corporation, 525 French Road, Utica, NY 13502;Attn: Field Action Support Team. PLEASE DO NOT RETURN USED DEVICES. If you have any questions or requests, please dont hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email stat2@conmed.com.

Device

Device Recall STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration a...
  • Model / Serial
    Catalog Number, Manufacturing Date range, Lot Code range: (1) S2, 4/27/12 - 2/1/17, 120427X - 201702014; (2) S2-12, 4/27/12 - 3/13/17, 120427X - 201703134; (3) S2-20 MD, 4/27/12 - 1/2/17, 120427X - 201701024; (4) S2V-20, 4/27/12 - 4/7/17, 120427X - 201704074; and (5) S2V-60, 4/27/12 - 3/16/17, 120427X - 201703164
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada.
  • Product Description
    STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) || The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. 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. This is a disposable device with a sterile, nonpyrogenic fluid path.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA