Recall Z-0175-2014 ยท JCC Ph Buffer
Mesa Laboratories, Inc.
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.
| Date | Nov 7, 2013 (initiated Sep 13, 2013) |
| Status | Terminated |
| Reason | Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 58,466 bottles |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.