Drug recall
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for…
FDA recall event 75966 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 75966 |
|---|---|
| Recall numbers | Z-1041-2017, Z-1042-2017 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing…, Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of 510k clearance for design modification. |
| Initiation date | Nov 11, 2016 |
| Report date | Jan 25, 2017 |
| 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: