The Recall Desk
HighFDA (Devices)·Z-3141-2024·Announced 2024-09-25

Alaris Syringe Module Model 8110 Infusion Pumps Recalled for Bent Connectors

CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.

What this means for you

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 of a critical medical device (infusion pump) where a manufacturing defect (bent connectors) may prevent device operation. No illnesses or injuries have been reported in the source, but the potential for delays in necessary infusion therapy represents a risk-of-harm scenario consistent with a High severity rating.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system.

Certain affected units may have bent female IUI (Inter-Unit Interface) connectors, which could render the device inoperable or cause delays in starting infusions or monitoring functions. Approximately 20,145 units have been affected.

The recalled devices were distributed nationwide throughout the United States and internationally to Australia, Belgium, Canada, Hungary, Kuwait, New Zealand, Qatar, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates. Affected device serial numbers and UDI-DI codes are identified in the recall notice for verification purposes.

The recalled product

Product
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device
Hazard
Affected units
20,145

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)

  • Model Number: 8110 UDI-DI codes: 10885403516047
  • 10885403515323
  • 10885403811043
  • 10885403811036
  • 10885403811012

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 · bent connector

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