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).
- Company
- Smith & Nephew Inc.
- Recall Initiated
- July 18, 2014
- Posted
- October 8, 2014
- Terminated
- August 5, 2015
- Recall Number
- Z-0041-2015
- Quantity
- 45,466
- Firm Location
- Saint Petersburg, FL
Reason for Recall
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Distribution
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.
Lot / Code Info
Item 66800912 Lot # M400071
Root Cause
Device Design
Action Taken
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.