Devices

Device Recall Cardinal Steam Biological Indicator

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
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ || 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 Cardinal Steam Biological Indicator

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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