Recall Z-0175-2014
Mesa Laboratories, Inc. · initiated September 13, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-0175-2014
- Initiated
- September 13, 2013
- Posted by FDA
- November 7, 2013
- Terminated
- August 8, 2016
- Product code
- JCC – Ph Buffer
- Quantity
- 58,466 bottles
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Recalling firm
- Mesa Laboratories, Inc., Lakewood, CO