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Terminated

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. .

FDA Recall Z-1900-2017 · Posted 2017-05-02

Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeGDF
Date Initiated2017-03-28
Date Terminated2017-06-29
Product Quantity570 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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