Recall Z-2959-2018— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2018-07-26, terminated 2020-03-30. It names one FDA 510(k) clearance: K172319. Product: 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.. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-26
- Terminated
- 2020-03-30
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.