Devices

Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm

Model / Serial
MED. Serial Numbers: 400000 through 405499 are subject to correction.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
Product Description
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Manufacturer
Steris Corporation Hopkins Facility
1 Event
- Recall of Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm

Manufacturer

Steris Corporation Hopkins Facility

Manufacturer Address
Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
Manufacturer Parent Company (2017)
Steris Plc
Source
USFDA

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