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FDANovember 11, 2016device

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, s...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of 510k clearance for design modification.

What to do

FDA enforcement status: Ongoing

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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