Reported Jun 11, 2014 · Terminated
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for…
Bayer Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Corp · 100 Global View Dr · Warrendale, PA · 15086-7601
Is this the product you have?
- 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.
- Lot codes and dates
- catalog number 3008895
material numbers 300823630099663009917
- with serial numbers
1,347 of 1,347 codes
1048200619200585200656300010100066144981000872003052006632002482006063000471040100182100187200442200037200716200111300051104110042810012820047920058620064820000930004510010710003710021320066520003420072220013430002710027210045710021520060120010920029820013510022010027310048210014120061520012120055820059330003610040111210100488200117200313200618200465
- catalog number 3008895
- Amount recalled
- 1347
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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