The Recall Desk
HighFDA (Devices)·Z-0175-2014·Announced 2013-11-13

Mesa Laboratories Recalls pH 7.0 Buffer Solution Due to Mold Growth

Mesa Laboratories is recalling specific lots of pH 7.0 Buffer Solution bottles because of mold growth. The product is used to calibrate pH meters in hemodialysis settings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves mold growth in a product used in a medical setting (hemodialysis), which fits the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution Pint and Quart Bottles. The recall is being conducted due to the presence of mold growth in the product. The affected bottles are packaged in plastic and are used in the hemodialysis setting to calibrate pH meters.

The recall includes 58,466 bottles with specific lot codes and expiration dates ranging from November 2013 to January 2015. The product was distributed nationwide in the United States and in Canada. Mesa Laboratories, Inc. is the recalling firm.

Consumers and healthcare facilities should check their inventory for the specific lot codes listed in the official recall notice. If the product matches the recalled lots, it should be removed from use and returned to the distributor or manufacturer according to the instructions provided by Mesa Laboratories.

The recalled product

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.
Manufacturer
Mesa Laboratories, Inc.
Category
Medical Device — Dialysis Supplies
Hazard
Affected units
58,466

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distributed nationwide across the United States.

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