FDA Device recall Z-1042-2017
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only
- FDA Device
- Class II
- ongoing
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only by Smith And Nephew, citing lack of 510k clearance for design modification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1042-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-11-11 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
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 fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Reason
Lack of 510k clearance for design modification.
Identifiers
| code_info | Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1042-2017%22
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