Infusion pump modules recalled because drops can damage the bezel assembly
CareFusion is recalling 2,574,396 BD Alaris Infusion Pump Modules 8100 because a dropped or jarred pump can suffer bezel damage causing under-infusion, over-infusion or unregulated flow.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The BD Alaris Infusion Pump Module 8100, REF 8100, along with the bezel assembly kits REF 49000437 and REF 49000270, is being recalled, together with new and updated documents including an Inspection Safety Reminder.
If the infusion pump is dropped or severely jarred, this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or failure of the pump module to calibrate. The firm states that dropped or jarred pumps should be removed from use, tested and inspected by qualified service personnel before reuse, and that the tip sheet, cleaning and disinfecting procedure and reference guide have been updated.
The recall covers 2,574,396 units, comprising all Alaris Pump Modules distributed after 19 June 2004. Distribution was worldwide, including nationwide in the United States and to Puerto Rico, Guam, American Samoa and the Northern Mariana Islands. The FDA has classified the recall as Class I, its most serious category.
Facilities should follow BD's inspection instructions and remove any dropped or jarred module from service until it has been checked.
The recalled product
- Product
- BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00…
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion pump
- Affected units
- 2,574,396
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- All Alaris Pump Modules distributed after June 19
- 2004. REF/UDI-DI: 8100/10885403810015
- 10885403810046
- 10885403810039
- 10885403222054
- 10885403517723
- 10885403213212
- 10885403211423
- 49000437/10885403471018
- 49000270/10885403247743
Distribution
Related recalls
Same manufacturer · CareFusion 303, Inc.
See all →- HighBD Pyxis MedBank Mini fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedStation ES fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Anesthesia Station fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedBank Tower fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Mini Main cabinets may overheat at fingerprint scanner
FDA (Devices) · 2026-06-10
Similar recalls
- SevereCareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects
FDA (Devices) · 2020-09-16
- SevereInfusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts
FDA (Devices) · 2021-05-19
- SevereInfusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
FDA (Devices) · 2021-08-18
- SevereCareFusion Recalls Alaris Pump Model 8100 Due to Bezel Plastic Weakening
FDA (Devices) · 2019-07-24
- CriticalAlaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk
FDA (Devices) · 2021-06-09
- SevereCareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements
FDA (Devices) · 2020-08-12