Z-0175-2014Class II

pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged...

Name: Z-0175-2014 pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged...
Creator: Mesa Laboratories, Inc.
Published: 2013-09-13
License: https://open.fda.gov/license/

Mesa Laboratories Inc / initiated 2013-09-13 / Terminated / root cause: manufacturing process

FDA source

Mesa Laboratories, Inc. began a recall of 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... on 2013-09-13. FDA classified it as Class II and gives the reason as "Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0175-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Posted: 2013-11-07
Terminated: 2016-08-08
Recalling firm: Mesa Laboratories Inc
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.
Product code: JCC Ph Buffer
Reason for recall: Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0175-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0175-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07

Product code JCC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)