The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1309-2021·Announced 2021-04-07

CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress

CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion…"

Plain-English summary

CareFusion 303, Inc. is recalling the BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad and the Pump Module Door Assembly Replacement Kit with Pump Module Keypad. The affected parts are identified by part numbers 49000239, 49000346, 49000438, and 49000439. The recall covers 160,300 units that were distributed worldwide, including the United States and various international markets.

The recall was initiated because the pump module keypad may lift, allowing fluid to enter the device. This fluid ingress can result in unresponsive keys, which may cause the module to continue infusion without alarming the PC unit, or it may necessitate a different pump module. Additionally, stuck keys may cause the PC unit to alarm and exhibit a Channel Error. These issues may result in infusion start delays, an inability to titrate medication, or infusion interruptions.

The recalled Pump Modules with Keypads were manufactured between January 23, 2019, and December 5, 2019. The Pump Module Door Assembly Kits with Keypads are dated from January 15, 2019, to November 14, 2019. Users should check their devices for these specific part numbers and dates to determine if they are affected.

The recalled product

Product
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
160,300

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 (5)

  • Pump Module with Keypad: manufactured January 23
  • 2019 to December 5
  • 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15
  • 2019 to November 14
  • 2019.

Distribution

Distributed nationwide across the United States.

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