The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3138-2024·Announced 2024-09-25

Infusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector

CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall without reported hospitalizations, illnesses, or injuries. The hazard—a bent connector that may prevent device operation or delay infusion—is theoretical rather than documented. Under the rubric, Class II without reported harm is at most score 3.

Plain-English summary

The Alaris System PC Unit Model 8015, manufactured by CareFusion 303, Inc., is being recalled due to a mechanical defect affecting approximately 125,017 devices distributed worldwide. This is an FDA Class II recall.

The affected devices may have a bent female IUI connector that could prevent the device from operating properly or cause delays in starting infusion or monitoring functions.

The recalled devices have been distributed to all U.S. states, territories, and internationally to countries including Australia, Belgium, Canada, Hungary, Kuwait, New Zealand, Qatar, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates.

Healthcare providers and patients possessing an affected device should contact CareFusion 303, Inc. for guidance on device replacement or remediation.

The recalled product

Product
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump System
Hazard
Affected units
125,017

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 (6)

  • Model Number: 8015 UDI-DI codes: 10885403516023
  • 10885403515231
  • 10885403801549
  • 10885403801532
  • 10885403801518
  • 10885403519284

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · connector defect

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