Events

Recall of pH 7.0 Buffer 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
    66475
  • Event Risk Class
    Class 2
  • Event Number
    Z-0175-2014
  • Event Initiated Date
    2013-09-13
  • Event Date Posted
    2013-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122454
  • 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
    Ph buffer - Product Code JCC
  • Reason
    Mesa laboratories, inc. is recalling certain lots of ph 7.0 buffer solution due to mold growth.
  • Action
    An email letter was sent to consignees on October 2, 2013 asking all customers to discard the product and a replacement product and tubing will be issued.

Device

pH 7.0 Buffer Solution
  • Model / Serial
    ML-P7-1110 Exp NOV 11 2013, ML-P7-1118 Exp JAN 12 2014, ML-P7-1122 Exp FEB 23 2014, ML-P7-1128 Exp APR 17 2014, ML-P7-1137 Exp JUN 17 2014, ML-P7-1138 Exp JUL 4 2014, ML-P7-1148 Exp SEP 14 2014, ML-P7-1149 Exp SEP 19 2014, ML-P7-1158 Exp DEC 7 2014, ML-P7-1164 Exp JAN 19 2015
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). || Used in the hemodialysis setting to calibrate pH meters.
  • 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