Reported Jun 3, 2015 · Terminated
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting…
Medrad Inc. dba Bayer R&I
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: Medrad Inc dba Bayer R&I · 1 Medrad Dr · Indianola, PA · 15051-9759
Is this the product you have?
- MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
- Lot codes and dates
- Material numbers
303245830073013010432
- with serial numbers
137 of 137 codes
1005437918379213671436721108405962383410065395332009229884334231002610028100321003510069298813035123741278771009520693305483331621089101231000824272371772598939003390093889438894388403884334894388333582438846261073707337472100581001010076247071009138400384033840438405403901009338999394343735137359
- Material numbers
- Amount recalled
- 133
Where it was sold
- Nationwide
Why it was recalled
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
This product could cause temporary or reversible health problems — stop using it.
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