Z-1900-2017Class II

MR GHIATAS Beaded Breast Localization Wire

Name: Z-1900-2017 MR GHIATAS Beaded Breast Localization Wire
Creator: Bard Peripheral Vascular Inc
Published: 2017-03-28
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2017-03-28 / Terminated

FDA source

Bard Peripheral Vascular Inc began a recall of MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer... on 2017-03-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1900-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Posted: 2017-05-02
Terminated: 2017-06-29
Recalling firm: Bard Peripheral Vascular Inc
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. .
Product code: GDF Guide, Needle, Surgical
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 root cause: Other
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.
Product codes and lots: REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1900-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1900-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-01

Product code GDF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)