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U.S. Department of Health and Human Services

Class 2 Device Recall MR GHIATAS Beaded Breast Localization Wire

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  Class 2 Device Recall MR GHIATAS Beaded Breast Localization Wire see related information
Date Initiated by Firm March 28, 2017
Date Posted May 02, 2017
Recall Status1 Terminated 3 on June 29, 2017
Recall Number Z-1900-2017
Recall Event ID 76914
Product Classification Guide, needle, surgical - Product Code GDF
Product MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201

Product Usage:
The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance.
Code Information REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884
Recalling Firm/
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
Manufacturer Reason
for Recall
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
FDA Determined
Cause 2
Action Bard sent an Urgent Medical Device Recall notification letter dated March 28, 2017 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact your Bard representative.
Quantity in Commerce 570 units
Distribution Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium.
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.