Recall Z-1136-2017— Medtronic Advanced Energy, LLC
Class II · Terminated
Class II FDA medical device recall by Medtronic Advanced Energy, LLC, initiated 2016-12-28, terminated 2017-05-11. It names one FDA 510(k) clearance: K003190. Product: Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm 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: Product sterility compromised due to breach of sterile barrier.
- Recalling firm
- Medtronic Advanced Energy, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-28
- Terminated
- 2017-05-11
- Firm location
- Portsmouth, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.