Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm 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.
FDA Recall Z-1129-2017 · Posted 2017-02-02
Advertisement
Recalling FirmMedtronic Advanced Energy, LLC
Recall StatusTerminated
Product CodeKNW
Date Initiated2016-12-28
Date Terminated2017-05-11
Product Quantity252 units
Reason for Recall
Product sterility compromised due to breach of sterile barrier
Firm Action
Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product.
Root Cause
Package design/selection
Distribution Pattern
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement