Events

Recall of Device Recall Conductivity/TDS Calibrator Solution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mesa Laboratories, 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
    77290
  • Event Risk Class
    Class 2
  • Event Number
    Z-2159-2017
  • Event Initiated Date
    2017-05-12
  • Event Date Posted
    2017-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155628
  • 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
    Solution-test standard-conductivity, dialysis - Product Code FKH
  • Reason
    Mesa laboratories is recalling conductivity/tds calibrator solution due to failure to meet product specifications.
  • Action
    MesaLabs sent an Device Correction Notice dated May 12, 2017, via certified letter to destroy product by pouring it down the drain and free replacements will be shipped. For further questions, please call (303) 987-8000 ext. 120.

Device

Device Recall Conductivity/TDS Calibrator Solution
  • Model / Serial
    Lot number: ML-C14-1352
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
  • Product Description
    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle || Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.
  • Manufacturer
    Mesa Laboratories, Inc.

Manufacturer

Mesa Laboratories, Inc.
  • Manufacturer Address
    Mesa Laboratories, Inc., 12100 W 6th Ave, Lakewood CO 80228-1252
  • Manufacturer Parent Company (2017)
    Mesa Laboratories Inc
  • Source
    USFDA