Bayer Corp recalls Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for pati

Recalled June 11, 2014 · FDA recall Z-1673-2014 · Bayer

Hazard

There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. · FDA Class II

Units

1347

Sold at

Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.

Description

There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

Product

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Manufacturer(s)

Bayer Corp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →