FDA-Device2014-03-05Class II
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Smith & Nephew Inc.
Hazard
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Sold states
Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.
Affected count
6,799,140 canisters EZ & EZ PLUS
Manufactured in
970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, United States
Products
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1067-2014Don't want to check this manually?
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