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

FDA device recall Z-0772-2018 · posted 2018-02-13 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

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

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:

Root cause

Device Design

Status

Terminated

Product code

MLR

Quantity affected

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

Date initiated

2017-09-28

Date posted

2018-02-13

Date terminated

2018-09-12

Location

Mentor, OH

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