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Bd alaris™ pump module and subset of compatible pump infusion sets

Official notice

24 Sept 2025

Last checked

24 Sept 2025

Medium riskHealth Canada
Watch Carefusion 303

An official Health Canada notice concerns Bd alaris™ pump module and subset of compatible pump infusion sets. 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. Published 2025-09-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78122

Official notice

2025-09-24

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.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

78122

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Affected products

Product 1

Affected products - BD Alaris™ Pump Module, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8100

Product 2

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

Product 3

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

Product 4

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

Product 5

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

Product 6

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

Product 7

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

Product 8

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

Product 9

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

Product 10

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

Product 11

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

Product 12

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

Product 13

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

Product 14

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

Product 15

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

Product 16

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

Product 17

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

Product 18

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

Product 19

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

Product 20

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

Product 21

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

Product 22

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

Product 23

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

Product 24

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

Product 25

Affected products - BD Alaris™ PCU, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8015

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Carefusion 303, Bd Switzerland Sarl, Bd Alaris™ Pump Module And Subset Of Compatible Pump Infusion Sets

Manufacturer

Not provided

Phone

Not provided

Brand: Carefusion 303, Bd Switzerland Sarl, Bd Alaris™ Pump Module And Subset Of Compatible Pump Infusion Sets.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

78122

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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