Device 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.
Z-1042-2017
Product summary
- Event
- Event 75966
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15,960 units (US )
- Official record key
device-enforcement:Z-1042-2017
Official wording
Reason: Lack of 510k clearance for design modification.
Code information: Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Lack of 510k clearance for design modification.