Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm

MED. Serial Numbers: 400000 through 405499 are subject to correction.

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.

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.