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Terminated

V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)

FDA Recall Z-0772-2018 · Posted 2018-02-13

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMLR
Date Initiated2017-09-28
Date Terminated2018-09-12
Product Quantity406

Reason for Recall

Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.

Firm 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 illustration:

Root Cause

Device Design

Distribution Pattern

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, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico, Morocco, Myanmar, Panama, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation · 2017-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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