Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1132-2017 — 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 hi

U.S. FDA — Device Enforcement · United States · 2016-12-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1132-2017
Date of alert: 2016-12-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Advanced Energy, LLC
Product category: device
Product type: Devices

Reported risk: Product sterility compromised due to breach of sterile barrier

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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