CareFusion 303, Inc.: BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey Quantity: 33,162,680 units total Lot/code info: BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

UPC codes

10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.