AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices in Healthcare Facilities.

There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.

The firm, Steris, sent an "Urgent Device Field Correction" letters dated 7/25/18 were distributed to customers. The letters included the following instructions for customers: STERIS Action The system software for V-PRO 1, V-PRO 1 Plus, and V-PRO maX will be updated to ensure the VAPROX HC Sterilant expiration date is detected regardless of whether the unit is powered on or off. STERIS Service Technicians will contact all affected Customers and update the system software in the affected V-PRO Sterilization Systems. User Action In the interim of the software update, as is normal practice, V-PRO 1, V-PRO 1 Plus, and V-PRO maX operators should place the unit into Standby mode when not in use in lieu of fully powering down the unit. As is stated in the Operator Manual, the unit should only be shut down during unit service activities as required: "Control Power Disconnect Switch - Located behind Operating End (OE) lower access door. This switch is used to disconnect power to the Sterilization Unit. Under normal operation, this switch remains in ON position at all times and is only accessed during sterilization unit servicing. This switch is designed to enable lock-out for maintenance purposes." In addition, users should continue to review their cycle printouts upon completion of each cycle to verify the VAPROX Sterilant was not expired. If you have questions regarding this matter, please contact Associate Product Manager, at (440) 392-7140, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.