Recall Z-1900-2017 ยท GDF Guide, Needle, Surgical
Bard Peripheral Vascular Inc
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 ultraso
| Date | May 2, 2017 (initiated Mar 28, 2017) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.