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U.S. Department of Health and Human Services

Class 2 Device Recall Intact Disposable Wands

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  Class 2 Device Recall Intact Disposable Wands see related information
Date Initiated by Firm December 28, 2016
Date Posted February 02, 2017
Recall Status1 Terminated 3 on May 11, 2017
Recall Number Z-1135-2017
Recall Event ID 76130
510(K)Number K003190  
Product Classification Instrument, biopsy - Product Code KNW
Product Intact Disposable Wands (part of the Intact System)
777-120BT: 5 Pack 20mm 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 996 units
Distribution Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = NEOTHERMIA CORP.
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