Reported Oct 1, 2014 · Terminated
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 970 Lake Carillon Dr · Saint Petersburg, FL · 33716-1130
Is this the product you have?
- RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
- Lot codes and dates
Model #'s 66800059all lots since product launched 01/16/2009
- Amount recalled
- 2,142 units
Where it was sold
Why it was recalled
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
This product could cause temporary or reversible health problems — stop using it.
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