FDAFDA · Food and drugs·Recall number Z-1126-2017
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm 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.
Published February 8, 2017 · Recall initiated: December 28, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product sterility compromised due to breach of sterile barrier
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Advanced Energy, LLC
- Distributor
- Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
- Lot
- All lot codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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