FDA Enforcement
Class II
Terminated
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.
Recall: Z-0175-2014
·
Reported November 13, 2013
Enforcement
- Recall Number
- Z-0175-2014
- Event ID
- 66475
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mesa Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2013
- Initiation Date
- September 13, 2013
- Classification Date
- November 7, 2013
- Termination Date
- August 8, 2016
- Address
- 12100 W 6th Ave, N/A, Lakewood, CO, 80228-1252, United States
Description
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.
Reason
Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
Code Info
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
Worldwide Distribution-USA (nationwide) and the country of Canada.
Quantity
58,466 bottles