CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

pH 0 Buffer Solution Pint and Quart recalled by Mesa Laboratories

Mesa Laboratories is recalling pH 0 Buffer Solution Pint and Quart, distributed nationwide in the US. The recall was initiated on 13 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesML-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

Quantity recalled58,466 bottles

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0175-2014
FDA event ID: 66475
Recalling firm: Mesa Laboratories, Lakewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 13 Sep 2013
FDA classified: 7 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Mold
Device type: Other Medical Devices

Timeline

13 Sep 2013	Recall initiated by company
7 Nov 2013	Classified by FDA	+55 days
13 Nov 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is pH 0 Buffer Solution Pint and Quart recalled?

Yes. Mesa Laboratories recalled pH 0 Buffer Solution Pint and Quart on 13 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0175-2014.

Why was it recalled?

Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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