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Medtronic Advanced Energy, LLC recalls Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medic
Recalled February 8, 2017 · FDA recall Z-1133-2017 · Medtronic Advanced Energy
Hazard
Product sterility compromised due to breach of sterile barrier · FDA Class II
Units
275 units
Sold at
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Description
Product sterility compromised due to breach of sterile barrier
Product
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Manufacturer(s)
Medtronic Advanced Energy, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →