Recall Z-0772-2018 ยท MLR Sterilizer, Chemical
Steris Corporation
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
| Date | Feb 13, 2018 (initiated Sep 28, 2017) |
| Status | Terminated |
| Reason | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle. |
| Root cause | Device Design |
| Action | 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 illust |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX L STERIS Corporation, Mar 31, 2017 |