Recall Z-2959-2018 ยท MLR Sterilizer, Chemical
Steris Corporation
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.
| Date | Jul 26, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 2889 units |
| Distribution | Worldwide Distribution: US(nationwide) and to countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX L STERIS Corporation, Jan 18, 2018 |