FDAMay 22, 2018device

ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

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

The hazard

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

What to do

FDA enforcement status: Terminated

Brands named

newdeal sanewdeal

Recall history

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

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