—#154553

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. .

FDA product code: GDF — Guide, Needle, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

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.

Timeline

Recall initiated: 2017-03-28
Posted by FDA: 2017-05-02
Terminated: 2017-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154553. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.