FDAFDA · Food and drugs·Recall number Z-2688-2014
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.
Published October 1, 2014 · Recall initiated: August 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.
- Lot
- Model #'s 66800059, all lots since product launched 01/16/2009
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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