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Showing 277–288 of 474 recalls
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglob…
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical…
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to…
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/tr…
The Drill stop kit contains incorrect components.
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.