Drug recall
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a…
FDA recall event 69137 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 69137 |
|---|---|
| Recall numbers | Z-2688-2014 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. |
| Initiation date | Aug 13, 2014 |
| Report date | Oct 1, 2014 |
| Termination date | Aug 6, 2015 |
| City | Saint Petersburg |
| State | FL |
| Country | United States |
| FEI number | 3006760724 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: