Medrad Stellant CT Injector System Recalled for Under-Volume Hazard
Medrad Inc dba Bayer R&I is recalling 133 Stellant CT Injector Systems with Certegra Workstations due to a configuration error that may cause under-infusion of contrast media.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of under-infusion of contrast media, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medrad Inc dba Bayer R&I is recalling 133 units of the MEDRAD Stellant CT Injector System with Certegra Workstation. These devices are intended for injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The units were distributed nationwide.
The recall is due to a root cause investigation finding that the units may experience an under-volume hazard. This occurs when the unit is configured to prime with contrast but instead primes with saline because the configuration data is not sent to the injector head. This non-optimal priming condition could lead to under-infusion of the contrast media.
Healthcare facilities and users should identify affected units by checking the material numbers 3032458, 3007301, or 3010432 and the associated serial numbers listed in the recall documentation. Users should contact the recalling firm for instructions on how to proceed with the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Medrad Inc dba Bayer R&I
- Category
- Medical Device — CT Injector
- Affected units
- 133
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Material numbers: 3032458
- 3007301
Distribution
Distributed nationwide across the United States.
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