FDA Device recall Z-1900-2017
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consist…
- FDA Device
- Class II
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class II recall of MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consist… by Bard Peripheral Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1900-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-28 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
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. .
Reason
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.
Identifiers
| code_info | REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1900-2017%22
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