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Recall Observatory FDA recall evidence

Device 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.

Z-0175-2014

September 13, 2013

Class II

Product summary

Firm
Mesa Laboratories, Inc.
Event
Event 66475
Status
Terminated
Classification
Class II
Quantity
58,466 bottles
Official record key
device-enforcement:Z-0175-2014

Official wording

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

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

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    mold growth