Reported Sep 12, 2018 · Terminated
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…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- 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.
- Lot codes and dates
UDI numbers 007249951519730072499515198000724995151997and 00724995152000007249951519970072499515467700724995154684and 00724995154691
- Serial numbersCc 1 A101
2,886 of 2,886 codes
012320701012320702033260705033250701033260706030630806030730804030770803030800806030890801030910801030850807031170801031540802031570820031030803031690801031700816031710847031500830031720801031860805031540803031220802032000818031650808031820810032110802032240802032250808032260801032290826032330801032320808032270808032290805032290825032330802032350801032210820032380801032380802032460801032460809032520802031500819031850801032520804032200804032460810032560801032680807031770802032670807032710803031500838032330808032200805032560802032700806
- Amount recalled
- 2889 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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