Recall Z-0772-2018
Steris Corporation · initiated September 28, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Codes / lots: Serial numbers: 031591505 031611402 032941412 031831609 030261761 033161412 030991616 032641604 031451507 031621401 031691412 032941414 032861406 032941415 033141452 032861409 033161411 030231501 033241412 033241413 033241414 030231504 030231505 030231507 030231509 030231502 033151407 030341528 030441516 030231506 030231508 030341524 030341535 030361549 030361550 030501523 030501524 030501525 030681530 030681532 030341527 030681531 030341532 030341530 030441517 030341533 030441518 032861410 030341529 030501526 032941413 031191508 033181425 030341526 030441519 030441520 030501528 031191511 031271517 031191509 031191510 031341503 031341504 031271520 031271524 031351514 031451508 031351510 031351515 031411503 030341534 031411501 031411502 031451511 031451512 031271518 031591501 031591502 031591509 031591510 031591512 030361552 031451506 031541506 031451503 031541501 031541502 031541505 031541507 031541504 031591503 031591504 030681534 031351513 031591513 031631513 031631512 031631510 032111549 032181502 031631514 031771513 031831519 031771510 031771511 030361551 031701509 032281501 032361504 031771508 031771509 032361501 032401540 032401543 032221503 032221504 032281502 032361502…
Reason for recall
Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
FDA-determined cause: Device Design
Action taken
The V-PRO 60 system software has been updated to ensure the VAPROX Sterilant expiration date is verified prior to the initiation of each sterilization cycle. STERIS Service Technicians will be contacting your facility to update your V-PRO 60 Sterilizer(s) with the revised system software. User Action Users should continue to review their V-PRO 60 cycle printouts upon completion of each cycle to verify the VAPROX Sterilant was not expired. The VAPROX Sterilant expiration date is identified near the top of each cycle printout following all sterilization cycles as notated in the following illustration:
Details
- Recall number
- Z-0772-2018
- Initiated
- September 28, 2017
- Posted by FDA
- February 13, 2018
- Terminated
- September 12, 2018
- Product code
- MLR – Sterilizer, Chemical
- Quantity
- 406
- Distribution
- Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt…
- Recalling firm
- Steris Corporation, Mentor, OH