FDAFDA · Food and drugs·Recall number Z-1829-2013
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
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.:130401
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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