The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2939-2020·Announced 2020-09-16

CareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects

CareFusion is recalling BD Alaris infusion pumps because fluid ingress can cause unresponsive or stuck keys, potentially delaying or interrupting infusions.

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 source text explicitly states that the defect can cause serious injury or death in high-risk patient populations, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or high-risk scenarios.

Plain-English summary

CareFusion 303, Inc. is recalling the BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439). The recall involves 248,519 units distributed worldwide, including the United States, Canada, Australia, and various other international locations.

The recall is being conducted because the Pump Module keypad may exhibit keys that are unresponsive or stuck. This issue can result from fluid ingress into the device. Such defects may lead to a delay in the start of an infusion or an interruption of an ongoing infusion.

According to the source text, delays or interruptions in infusion can cause serious injury or death in high-risk patient populations. The recall covers all serial numbers of the affected product.

The recalled product

Product
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
248,519

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 (1)

  • All serial numbers

Distribution

Distributed in 54 states:

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