Events

Recall of STAT 2 Pumpette

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
    60703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0685-2012
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106380
  • 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 16 complaints for stat 2 pumpette¿ devices for inaccurate flow rates and for leakage from the body of the compensating controller. the investigation of the complaints determined that the stat 2 pumpette¿ compensating controller on several complaint samples had been assembled incorrectly.
  • Action
    ConMed sent an "Urgent Medical Device Recall" letters and Reply Forms dated April 15, 2011 to the domestic consignees via UPS Priority Mail pouches and to the foreign consignees via FedEx International Priority. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to review their inventory and immediately stop use of the affected devices and return them to ConMed Corporation. Consignees who had distributed the affected products outside of their facility were instructed to immediately notify their customers of the recall and provide them with a copy of this notice. Consignees were asked to complete and return the enclosed Reply Form. For questions call 315-624-3237 or email ivcontroller@conmed.com

Device

STAT 2 Pumpette
  • Model / Serial
    Beginning Lot Code 0603241, Ending Lot Code 1103114
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) - including the countries of: Australia, Barbados, Belgium, Bermuda, Canada, Egypt, Israel, India, Italy, Korea, New Zealand, Philippines and Saudi Arabia.
  • Product Description
    STAT 2 Pumpette¿ Primary Administration Set Gravity Flow Compensating Controller, 20 Drops/cc, 84" length, Catalog/REF No. P-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. || Product Usage: || The STAT 2 Pumpette¿ 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 Pumpette¿ 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 Road, Utica NY 13502
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA