RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction devi
FDA device recall Z-2688-2014 · posted 2014-09-23 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 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, Ne
- Date initiated
- 2014-08-13
- Date posted
- 2014-09-23
- Date terminated
- 2015-08-06
- Location
- Saint Petersburg, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENASYS EZ (K082426) | Smith & Nephew, Inc. | 2008-09-05 |