Devices

Device Recall Medline Steam Biological Indicators

Model / Serial
Affected Biological Indicator Lot No.: S-444
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
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 || EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Manufacturer
Steritec Products Mfc. Co., Inc.
1 Event
- Recall of Device Recall Medline Steam Biological Indicators

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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