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.
- Company
- Smith & Nephew Inc.
- Recall Initiated
- August 13, 2014
- Posted
- September 23, 2014
- Terminated
- August 6, 2015
- Recall Number
- Z-2688-2014
- Quantity
- 2,142 units
- Firm Location
- Saint Petersburg, FL
Reason for Recall
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Distribution
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 / Code Info
Model #'s 66800059, all lots since product launched 01/16/2009
Root Cause
No Marketing Application
Action Taken
All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time.