BD Alaris™ Pump Module and subset of Compatible Pump Infusion Sets
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
BD Alaris™ Pump Module |
More than 10 numbers, contact manufacturer. |
8100 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2430-0500 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10561554 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2465-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10010453 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10010454 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
11532269 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
11171447 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10013186 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10015645 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10062818 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10015414 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2426-0500 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10010483 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10015012 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2452-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10015414 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2204-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10863358 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2202-0500 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2202-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2432-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2430-0500 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2403-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
2426-0007 |
Subset Of BD Alaris™ Compatible Pump Infusion Sets |
More than 10 numbers, contact manufacturer. |
10942011 |
BD Alaris™ PCU |
More than 10 numbers, contact manufacturer. |
8015 |
Multiple Variants Of BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing |
More than 10 numbers, contact manufacturer. |
10015861A |
Multiple Variants Of BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing |
More than 10 numbers, contact manufacturer. |
24601-B007T |
BD Alaris™ Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite™ Y-Sites |
More than 10 numbers, contact manufacturer. |
10015896 |
BD Alaris™ Pump Infusion Set, PE Lined Tubing |
More than 10 numbers, contact manufacturer. |
2260-0500 |
BD Alaris™ Pump Infusion Blood Set, 180 Micron Filter, SmartSite™ Y-Site |
More than 10 numbers, contact manufacturer. |
2477-0007 |
BD Alaris™ Pump Infusion Set, Yellow-Striped Microbore Tubing |
More than 10 numbers, contact manufacturer. |
2206-0007 |
BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer | Bd Alaris LVP 20D Low Sorb |
More than 10 numbers, contact manufacturer. |
11426964 |
BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer | Bd Alaris LVP 20D Low Sorb |
More than 10 numbers, contact manufacturer. |
22603-B007T |
BD Alaris™ Pump Infusion Set, Back Check Valve, 2 SmartSite™ Y-Sites |
More than 10 numbers, contact manufacturer. |
2420-0500 |
Multiple Variants BD Alaris™ Pump Infusion Set, Back Check Valve |
More than 10 numbers, contact manufacturer. |
10013361 |
Multiple Variants BD Alaris™ Pump Infusion Set, Back Check Valve |
More than 10 numbers, contact manufacturer. |
10013361T |
Multiple Variants BD Alaris™ Pump Infusion Set, Back Check Valve |
More than 10 numbers, contact manufacturer. |
24010-0007T |
BD Alaris™ Pump Infusion Burette Set, Smallbore Tubing, SmartSite™ Port (Burette), 3 SmartSite™ Y-Sites |
More than 10 numbers, contact manufacturer. |
2441-0007 |
Multiple Variants BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing |
More than 10 numbers, contact manufacturer. |
10015862 |
Multiple Variants BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing |
More than 10 numbers, contact manufacturer. |
2466-0007 |
Multiple Variants BD Alaris™ Pump Infusion Set, SmartSite™ Bag Access Non-Vented, PE Lined Tubing |
More than 10 numbers, contact manufacturer. |
22602-B007T |
Issue
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.
Additional information
Details
Carefusion 303, Inc.
10020 Pacific Mesa Blvd., San Diego, California, United States, 92121
Bd Switzerland Sarl
Route De Crassier 17, Eysins, Switzerland, 1262
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