Reported Sep 14, 2016 · Terminated
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial…
Bayer Healthcare
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 Healthcare · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications
- Lot codes and dates
- Serial Numbers
164 of 164 codes
KSA0517595KSA0518535KSA0519948KSA0518539KSA0518498KSA0517618KSA0518500DKSA0518536KSA0518456KSA0518504KSA0518520KSA0519940KSA0518507KSA0519991KSA0517568KSA0517592KSA0517649KSA0518496KSA0518508KSA0519971KSA0518534KSA0517600KSA0517566KSA0517587KSA0518469KSA0518452KSA0518460KSA0518532KSA0518516KSA0519946KSA0517641KSA0519968KSA0519941KSA0518399KSA0518479KSA0517609KSA0517617KSA0518446KSA0518453KSA0518410KSA0518466KSA0517581KSA0517574KSA0518524KSA0519956KSA0518459KSA0518495KSA0518481KSA0518513KSA0518528KSA0519989KSA0518429KSA0518523KSA0517620KSA0518509KSA0517634KSA0519964KSA0518418KSA0518474KSA0518526
- Serial Numbers
- Amount recalled
- 165 systems
Where it was sold
- Nationwide
Why it was recalled
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
This product could cause temporary or reversible health problems — stop using it.
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