CareFusion 303, Inc.: BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion S

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: REF: 10013186/ UDI: 07613203021173; REF: 2452-0007/ UDI: 10885403219870; REF: 2204-0007/ UDI: 10885403199363; REF: 24001-0007/ UDI: 10885403238666; REF: 10015012/ UDI: 10885403233951; REF: 2432-0007/ UDI: 10885403232329; REF: 2434-0007/ UDI: 07613203019682; REF: 2202-0007/ UDI: 10885403274039; REF: 11426965/ UDI: 10885403232558; REF: 10561554/ UDI: 10885403232565; REF: 10863358/ UDI: 10885403232466; REF: 11171447/ UDI: 07613203021234; REF: 11532269/ UDI: 10885403232343; REF: 10010454/ UDI: 07613203015806; REF: 2465-0007/ UDI: 10885403221941; REF: 10010453/ UDI: 07613203021135 REF: 11419365/ UDI: 10885403234736 REF: 10813621/UDI: 10885403234514 REF: 2423-0007/UDI: 07613203020985 REF: 10015896/UDI: 10885403234064 REF: 24010-0007T/UDI: 10885403271021 REF: 10010483/UDI: 10885403232602 REF: 2403-0007/UDI: 10885403232473 REF: 24301-0007T/UDI: 10885403223198

UPC codes

07613203021173, 10885403219870, 10885403199363, 10885403238666, 10885403233951, 10885403232329, 07613203019682, 10885403274039, 10885403232558, 10885403232565, 10885403232466, 07613203021234, 10885403232343, 07613203015806, 10885403221941, 07613203021135, 10885403234736, 10885403234514, 07613203020985, 10885403234064, 10885403271021, 10885403232602, 10885403232473, 10885403223198

Source

Official record: FDA (Device enforcement) ↗

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