FDA (Devices) recall action 97067
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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 bolos volume.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.