Recall Z-2688-2014 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew, Inc.
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.
| Date | Sep 23, 2014 (initiated Aug 13, 2014) |
| Status | Terminated |
| Reason | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. |
| Root cause | No Marketing Application |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082426 | RENASYS EZ Smith & Nephew, Inc., Sep 5, 2008 |