CanadaWhat's being recalled
Companies: Carefusion 303, Inc., 10020 Pacific Mesa Blvd., San Diego, California, United States, 92121, Bd Switzerland Sarl, Route De Crassier 17, Eysins, Switzerland, 1262.
How to identify it
Affected products: BD Alaris™ Pump Module; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8100
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2430-0500
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10561554
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2465-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10010453
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10010454
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11532269
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11171447
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10013186
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015645
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10062818
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015414
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2426-0500
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10010483
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015012
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2452-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015414
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2204-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10863358
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2202-0500
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2202-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2432-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2430-0500
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2403-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2426-0007
Affected products: Subset Of BD Alaris™ Compatible Pump Infusion Sets; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10942011
Affected products: BD Alaris™ PCU; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8015
Affected products: Multiple Variants Of BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015861A
Affected products: Multiple Variants Of BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 24601-B007T
Affected products: BD Alaris™ Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite™ Y-Sites; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015896
Affected products: BD Alaris™ Pump Infusion Set, PE Lined Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2260-0500
Affected products: BD Alaris™ Pump Infusion Blood Set, 180 Micron Filter, SmartSite™ Y-Site; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2477-0007
Affected products: BD Alaris™ Pump Infusion Set, Yellow-Striped Microbore Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2206-0007
Affected products: BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer | Bd Alaris LVP 20D Low Sorb; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11426964
Affected products: BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer | Bd Alaris LVP 20D Low Sorb; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 22603-B007T
Affected products: BD Alaris™ Pump Infusion Set, Back Check Valve, 2 SmartSite™ Y-Sites; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2420-0500
Affected products: Multiple Variants BD Alaris™ Pump Infusion Set, Back Check Valve; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10013361
Affected products: Multiple Variants BD Alaris™ Pump Infusion Set, Back Check Valve; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10013361T
Affected products: Multiple Variants BD Alaris™ Pump Infusion Set, Back Check Valve; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 24010-0007T
Affected products: BD Alaris™ Pump Infusion Burette Set, Smallbore Tubing, SmartSite™ Port (Burette), 3 SmartSite™ Y-Sites; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2441-0007
Affected products: Multiple Variants BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10015862
Affected products: Multiple Variants BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2466-0007
Affected products: Multiple Variants BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 22602-B007T
The hazard
BD is initiating this voluntary recall notice to inform customers of worse performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets (see Appendix A). Pump infusion set design features such as in-line filters, back check valves, and Y-sites were identified to adversely impact infusion performance, particularly at programmable rates under 1 mL/h and at or under 1 mL of volume. Compared to the performance described in the user manual, the flow rate and bolus dose accuracy for a subset of compatible pump infusion sets have decreased, and the time to alarm for upstream and downstream occlusions and associated post-occlusion bolus have increased. In this letter, BD is sharing the latest performance data, reiterating existing warnings and mitigations from user manuals, and requesting customers to acknowledge and disseminate this notice within their institutions.
Update (2026-09-28): BD will issue an updated recall notice as some Alaris™ pump sets with restrictive components and designs (e.g., closed male luer, filters, check valves, y-sites, microbore tubing, etc.) Perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 ml/h and at or under 5 ml of "bolus volume". BD has continued to extensively test BD Alaris™ pump infusion sets to ensure the most accurate set performance data is shared with our customers. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States