Date Initiated by Firm | December 28, 2016 |
Date Posted | February 02, 2017 |
Recall Status1 |
Terminated 3 on May 11, 2017 |
Recall Number | Z-1132-2017 |
Recall Event ID |
76130 |
510(K)Number | K003190 |
Product Classification |
Instrument, biopsy - Product Code KNW
|
Product | 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 histologic examination with partial removal of a palpable abnormality. |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Medtronic Advanced Energy, LLC 180 International Dr Portsmouth NH 03801-6837
|
For Additional Information Contact | 603-742-1515 |
Manufacturer Reason for Recall | Product sterility compromised due to breach of sterile barrier |
FDA Determined Cause 2 | Package design/selection |
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. |
Quantity in Commerce | 499 units |
Distribution | Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KNW
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