Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product...
FDA Recall #Z-1132-2017 — Class II — December 28, 2016
Product Description
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.
Reason for Recall
Product sterility compromised due to breach of sterile barrier
Recalling Firm
Medtronic Advanced Energy, LLC — Portsmouth, NH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
499 units
Distribution
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Code Information
All lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated