RENASYS EZ/ RENASYS EZ Plus 800 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).
FDA Recall Z-0040-2015 · Posted 2014-10-08
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeOMP
Date Initiated2014-07-18
Date Terminated2015-08-05
Product Quantity77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))
Reason for Recall
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Firm Action
Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.