FDA recall Z-0772-2018

Product

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

Reason for recall

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

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, 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.

Key facts

Status

Terminated

Initiation date

2017-09-28

Report date

2018-03-07

Termination date

2018-09-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0772-2018