Z-1900-2017 Class II Terminated
FDA device recall Z-1900-2017 was initiated by Bard Peripheral Vascular Inc on March 28, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 29, 2017). Affected quantity: 570 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2017
- Initiation Date
- March 28, 2017
- Termination Date
- June 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 570 units
Product Description
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 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.
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.
Code Information
REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884