Alaris 8120 (UDI 10885403494291)Recalls & reported problems

Carefusion 303, Inc. · Alaris PCA Module · Class 2

All models of BD Alaris Infusion System (29) · Alaris (25)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403494291), received between Mar 30, 2021 and Aug 30, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K043299); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Aug 15, 2024Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3139-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Device Alarm System2
Physical Resistance/Sticking2
Crack1

Patient problems

No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17658710 ↗
MalfunctionAug 18, 2023Crack; Crack
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17576270 ↗
MalfunctionOct 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15559235 ↗
MalfunctionMar 30, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 351.6760. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11590926 ↗
MalfunctionMar 30, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 351.6760. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11589472 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043299. One submission often covers many models, so check the product and lot details in each record.

Z-2882-2020 · Aug 4, 2020 · Open, Classified
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
Z-1711-2008 · Mar 5, 2008 · Terminated
Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (
Z-1712-2008 · Mar 5, 2008 · Terminated
U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a

Device details

UDI-DI	`10885403494291`
Brand	Alaris
Model	8120
Company	Carefusion 303, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	K043299
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	May 6, 2024

Device type (GMDN): Bedside syringe pump

A mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

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All Pump, infusion, pca devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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