BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0175-2014 · Initiated September 13, 2013

    Recall

    Recall Number
    Z-0175-2014
    Event Number
    66475
    Firm
    Mesa Laboratories, Inc.
    FEI Number
    1720309
    Product Code
    JCC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 13, 2013
    Posted
    November 7, 2013
    Terminated
    August 8, 2016
    Address
    12100 W 6th Ave, Lakewood, CO, 80228-1252

    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.

    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.

    Distribution

    Worldwide Distribution-USA (nationwide) and the country of Canada.

    Quantity

    58,466 bottles