Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR 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
Enforcement
- Recall Number
- Z-1828-2013
- Event ID
- 65473
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Steritec Products Mfc. Co., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 7, 2013
- Initiation Date
- June 10, 2013
- Classification Date
- July 29, 2013
- Termination Date
- December 19, 2013
- Address
- 74 Inverness Drive East, N/A, Englewood, CO, 80112-5114, United States
Description
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR 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
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.
Affected Biological Indicator Lot No.:130401
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
3535 units