Medtronic Advanced Energy, LLC recalls Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical…

Recall date

December 28, 2016

Source

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

Recall number

Z-1132-2017

FDA classification

Class II

Brand / firm

Medtronic Advanced Energy, LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.

Why it was recalled

Product sterility compromised due to breach of sterile barrier

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

What was recalled

Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm 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.