Atlas FDA

MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Locali

FDA device recall Z-1900-2017 · posted 2017-05-02 · Terminated

Recall details

Recalling firm
Bard Peripheral Vascular Inc
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.
Action taken
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
Status
Terminated
Product code
GDF
Quantity affected
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.
Date initiated
2017-03-28
Date posted
2017-05-02
Date terminated
2017-06-29
Location
Tempe, AZ

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.