Recall Z-2688-2014
Smith & Nephew, Inc. · initiated August 13, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model #'s 66800059, all lots since product launched 01/16/2009
Reason for recall
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
FDA-determined 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.
Details
- Recall number
- Z-2688-2014
- Initiated
- August 13, 2014
- Posted by FDA
- September 23, 2014
- Terminated
- August 6, 2015
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 2,142 units
- 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.
- Recalling firm
- Smith & Nephew, Inc., Saint Petersburg, FL