Reported Feb 8, 2017 · Terminated
Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical…
Medtronic Advanced Energy, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Advanced Energy, LLC · 180 International Dr · Portsmouth, NH · 03801-6837
Is this the product you have?
- Intact Disposable Wands (part
- of the Intact System) 777-1125
- Pack 12mm Disposable Product UsageThe 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
- Lot codes and dates
- All lot codes
- Amount recalled
- 180 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Product sterility compromised due to breach of sterile barrier
This product could cause temporary or reversible health problems — stop using it.
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