Reported Aug 7, 2013 · Terminated
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam…
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?
Medline Steam Biological IndicatorsSteriTec Product Code PL 353Distributor Product Code MDS200525
- 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
- 8200 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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