Recall Z-2959-2018
Steris Corporation · initiated July 26, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2959-2018
- Initiated
- July 26, 2018
- Terminated
- March 30, 2020
- Product code
- MLR – Sterilizer, Chemical
- 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, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel…
- Recalling firm
- Steris Corporation, Mentor, OH