Devices

Device Recall Mesa Labs SmartRead 105 EZ Test BI Test Pack

Model / Serial
Affected Biological Indicator Lot No.:130301
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
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 || The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
Manufacturer
Steritec Products Mfc. Co., Inc.
1 Event
- Recall of Device Recall Mesa Labs SmartRead 105 EZ Test BI Test Pack

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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