SteriTec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103

• 2 recalls, same reason

  • Terminated Z-1828-2013 FDA Class II ·initiated 10 Jun 2013
  • Terminated Z-1829-2013 FDA Class II ·initiated 10 Jun 2013

  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.

510(k) Number

K001444 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K003533 Active Cleared 7 Feb 2001

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See all devices from Steritec Products, Inc. →

• What is the SteriTec Steam Biological Test Pack used for?

  The SteriTec Steam Biological Test Pack with Instant Readout Integrator is designed for biological testing of pre-vacuum steam sterilizers operating at 134°C for 3 minutes or longer. It helps verify sterilization processes in hospital settings.

• How is the SteriTec Steam Biological Test Pack supplied?

  The test pack is supplied as a single-use device. It includes an Instant Readout Integrator Card that provides operators with a prediction of the biological test outcome, allowing for immediate assessment of sterilization effectiveness.

• What are the storage requirements for the SteriTec Steam Biological Test Pack?

  The device should be stored according to manufacturer instructions. The specific storage conditions aren't detailed in the provided information, but it's important to follow the manufacturer's guidelines to maintain the integrity of the biological indicators and instant readout integrator.

• Is the SteriTec Steam Biological Test Pack MRI compatible?

  No, the SteriTec Steam Biological Test Pack is not MRI compatible. It is specifically designed for steam sterilization monitoring and should not be used in MRI environments or for any purpose other than its intended sterilization verification function.

• What is the regulatory classification of the SteriTec Steam Biological Test Pack?

  The device has FDA 510(k) clearance with product code JOJ and is classified as a Class II medical device. It received clearance on May 15, 2000, and is substantially equivalent to other devices in its class for general hospital use.