The Recall Desk

FDA (Devices) recall action 65544

Mesa Laboratories, Inc., Bozeman Manufacturing Facility recalled 2 products on 2013-08-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-08-07
Critical
0
Units
—

Why these products were recalled

Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Devices)··2013-08-07

    Mesa Smart-Read EZTEST Biological Indicator Monitor Recall for Labeling Error

    Mesa Laboratories is recalling Smart-Read EZTEST Biological Indicator Monitoring Systems because the read-out time does not match label claims.

    Product
    Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-08-07

    Mesa EZtest Biological Indicator Monitor Recall for Readout Time Issues

    Mesa Laboratories is recalling EZtest biological indicator monitoring systems because the readout time does not match label claims.

    Product
    Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
    Category
    Distribution
    0 states