Recalls / —
—#129971
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).
- FDA product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K082426, K102001
- Affected lot / code info
- Item 66800912 Lot # M400071
Why it was recalled
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 970 Lake Carillon Dr, Ste 110, Saint Petersburg, Florida 33716-1130
Distribution
- 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.
Timeline
- Recall initiated
- 2014-07-18
- Posted by FDA
- 2014-10-08
- Terminated
- 2015-08-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #129971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.