Recall Z-0175-2014— Mesa Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Mesa Laboratories, Inc., initiated 2013-09-13, terminated 2016-08-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth..
- Recalling firm
- Mesa Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-13
- Terminated
- 2016-08-08
- Firm location
- Lakewood, CO, United States
Product 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 for recall
Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
Data sourced from openFDA. This site is unofficial and independent of the FDA.