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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.

FDA Recall Z-0175-2014 · Posted 2013-11-07

Recalling FirmMesa Laboratories, Inc.
Recall StatusTerminated
Product CodeJCC
Date Initiated2013-09-13
Date Terminated2016-08-08
Product Quantity58,466 bottles

Reason for Recall

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

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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