FDA-Device2014-03-05Class II
Renasys EZ PLUS, 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
6,871,375 canisters
Manufactured in
970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, United States
Products
Renasys EZ PLUS, 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-1068-2014Don't want to check this manually?
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