FDAFDA · Food and drugs·Recall number Z-1822-2013
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa 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.
Published August 7, 2013 · Recall initiated: June 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Distributor
- Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
- Lot
- Affected Biological Indicator Lot No.: S-444
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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