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Smith & Nephew, Inc. recalls RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus
Recalled October 15, 2014 · FDA recall Z-0041-2015 · Smith & Nephew
Hazard
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. · FDA Class II
Units
45,466
Sold at
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.
Description
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Product
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) 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).
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →