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 no
Check against the official notice below — it lists the full affected range.
Steris Corporation has recalled 2,889 V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems that use VAPROX HC sterilant. These sterilization systems have a potential safety issue where if a punctured cup of sterilant expires while the system is powered down, the unit will not detect the expired sterilant when it powers back up. This could allow subsequent sterilization cycles to run using expired sterilant. The affected devices have been distributed worldwide, including throughout the United States and to numerous international locations.
The recall involves specific UDI numbers and serial numbers identified in the record. However, the source document does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Ita Quantity: 2889 units Lot/code info: UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 00724995154684, and 00724995154691. Serial numbers: 012320701 012320702 033260705 033250701 033260706 030630806 030730804 030770803 030800806 030890801 030910801 030850807 031170801 031540802 031570820 031030803 031690801 031700816 031710847 031500830 031720801 031860805 031540803 031220802 032000818 031650808 031820810 032110802 032240802 032250808 032260801 032290826 032330801 032320808 032270808 032290805 032290825 032330802 032350801 032210820 032380801 032380802 032460801 032460809 032520802 031500819 031850801 032520804 032200804 032460810 032560801 032680807 031770802 032670807 032710803 031500838 032330808 032200805 032560802 032700806 032560804 032750827 032560803 031030802 032750831 032740804 032750832 032820802 032820804 032820803 032820808 032820809 032970828 032820807 032940807 031800802 033010803 033010804 032990805 033080801 033170834 033170833 033110806 033170832 033170835 033290812 032920825 033080802 033120802 033290810 032950811 033170831 033290811 033640813 033080803 033480809 033650803 033650802 033660801 030060912 030060910 030060913 032810803 033530807 033530808 030080911 033120801 033120803 033120804 033240816 033240817 033240818 033240819 030300909 032810805 030130939 030160913 030210902 030220901 030270928 030270929 030280910 030400927 030080909 030080912 030540902 030610909 030480911 030420917 030610902 030440914 030610910 030490906 030490
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.