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U.S. Department of Health and Human Services

Class 2 Device Recall pH 7.0 Buffer Solution

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  Class 2 Device Recall pH 7.0 Buffer Solution see related information
Date Initiated by Firm September 13, 2013
Date Posted November 07, 2013
Recall Status1 Terminated 3 on August 08, 2016
Recall Number Z-0175-2014
Recall Event ID 66475
Product Classification Ph buffer - Product Code JCC
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Mesa Laboratories, Inc.
12100 W 6th Ave
Lakewood CO 80228-1252
For Additional Information Contact James K. Louie
303-565-4846
Manufacturer Reason
for Recall		 Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
FDA Determined
Cause 2		 Material/Component Contamination
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.
Quantity in Commerce 58,466 bottles
Distribution Worldwide Distribution-USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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