FDA-Device2014-10-15Class II
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Smith & Nephew, Inc.
Hazard
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Sold states
Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.
Affected count
19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))
Manufactured in
970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, United States
Products
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2015Don't want to check this manually?
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