Devices

Device Recall Cardinal BI Stat Biological Test Pack with Instant Readout Integrator

Model / Serial
Affected Biological Indicator Lot No.:130401
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Product Description
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.
Manufacturer
Steritec Products Mfc. Co., Inc.
1 Event
- Recall of Device Recall Cardinal BI Stat Biological Test Pack with Instant Readout Integrator

Manufacturer

Steritec Products Mfc. Co., Inc.

Manufacturer Address
Steritec Products Mfc. Co., Inc., 74 Inverness Drive East, Englewood CO 80112-5114
Manufacturer Parent Company (2017)
Steritec Product Mfg. Co. Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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