FDA-Device2017-01-25Class II
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.
Smith & Nephew, Inc.
Hazard
Lack of 510k clearance for design modification.
Sold states
Nationwide
Affected count
15,960 units (US )
Manufactured in
970 Lake Carillon Dr Ste 110, Saint Petersburg, FL, United States
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1042-2017Don't want to check this manually?
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