Smith & Nephew, Inc. recalls Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suc…

Recall date

November 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1041-2017

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of 510k clearance for design modification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.