Reported Aug 7, 2013 · Terminated
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest…
Steritec Products Mfc. Co., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steritec Products Mfc. Co., Inc. · 74 Inverness Drive East · Englewood, CO · 80112-5114
Is this the product you have?
- EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400
- EZTest Steam Biological IndicatorMesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours
- Lot codes and dates
- Affected Biological Indicator Lot No.: S-444
- Amount recalled
- 14,900 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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