FDA-Device2017-01-25Class II
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 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 in the US
Manufactured in
970 Lake Carillon Dr Ste 110, Saint Petersburg, FL, United States
Products
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 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-1041-2017Don't want to check this manually?
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