The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2909-2020·Announced 2020-09-16

CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect

CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication 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 for high-risk patient populations receiving life-sustaining infusions, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris System PC Unit Model 8015 infusion pump. The recall involves 313,740 units manufactured from April 07, 2017, to the present. These units were distributed across all 50 U.S. states, the District of Columbia, and various international locations.

The recall is due to a defect where the pump module keypad may exhibit unresponsive or stuck keys as a result of fluid ingress. This malfunction can result in a delay to the start of infusion, an interruption of infusion, or an inability to titrate medication. For high-risk patient populations receiving life-sustaining infusions, these delays or interruptions can cause serious injury or death.

Healthcare facilities and users should contact CareFusion 303, Inc. for instructions on how to address the defect. The source text does not specify a specific consumer action for home users, as the product is a medical device typically used in clinical settings.

The recalled product

Product
Alaris System PC Unit Model 8015
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
313,740

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 (2)

  • All serial numbers manufactured from April 07
  • 2017 to Present.

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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