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Alaris 8015

by CareFusion 303, INC GUDID

Listed FDA GUDID listing, not in commercial distribution Open recall

Regulatory status

as of 28 Oct 2026

Recall ongoing. 7 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885403801518 UDI-DIDate8 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

26 recalls · 7 ongoing · FDA

    • Ongoing Z-1645-2026 FDA Class II initiated 11 Feb 2026

    Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

  • 3 recalls, same reason

    • Ongoing Z-0184-2024 FDA Class I initiated 15 Sep 2023
    • Ongoing Z-0186-2024 FDA Class I initiated 15 Sep 2023
    • Ongoing Z-0185-2024 FDA Class I initiated 15 Sep 2023

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

  • 3 recalls, same reason

    • Ongoing Z-1360-2020 FDA Class I initiated 4 Feb 2020
    • Ongoing Z-1362-2020 FDA Class I initiated 4 Feb 2020
    • Ongoing Z-1361-2020 FDA Class I initiated 4 Feb 2020

    1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

    • Terminated Z-2671-2017 FDA Class II initiated 12 Jun 2017

    BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.

    • Terminated Z-1520-2017 FDA Class II initiated 1 Nov 2016

    Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

    • Terminated Z-2064-2016 FDA Class II initiated 12 May 2016

    A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

    • Terminated Z-1606-2016 FDA Class II initiated 24 Mar 2016

    The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.

    • Terminated Z-1239-2016 FDA Class II initiated 12 Feb 2016 on shared 510(k) K051641

    CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

    • Terminated Z-1811-2015 FDA Class II initiated 13 May 2015

    An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.

    • Terminated Z-1311-2015 FDA Class II initiated 12 Mar 2015

    CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.

    • Terminated Z-0534-2014 FDA Class I initiated 5 Dec 2013

    CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

    • Terminated Z-1835-2013 FDA Class I initiated 17 Jun 2013

    CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.

    • Terminated Z-1098-2013 FDA Class I initiated 6 Mar 2013

    The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

    • Terminated Z-1112-2013 FDA Class II initiated 6 Mar 2013

    The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s

    • Terminated Z-2076-2012 FDA Class I initiated 25 May 2012

    The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.

    • Terminated Z-0876-2012 FDA Unclassified (pre-2012) initiated 13 Sep 2011

    The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely.

    • Terminated Z-0492-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010

    Than recall was initiated because CareFusion has identified identified a potential risk associated with the Alaris PC unit formerly known as Medley PC unit (PC Unit) model 8000 only when used with Alaris Pump module (Pump module) or Alaris Syringe module' (Syringe module), This recall notification details the potential risk and recommended steps for users to take if they encounter a specific PC

    • Terminated Z-0006-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2010

    Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this potential risk associated with the Alaris PC unit model 8015 only (PC Unit) manufactured between December-2008 and September-2009.

    • Terminated Z-1791-2009 FDA Unclassified (pre-2012) initiated 12 Jun 2009

    Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of the Alaris PC unit when used in conjunction with the Alaris PCA module. When the Alaris PC unit detects a programmed infusion for the Alaris PCA module that exceed

    • Terminated Z-1792-2009 FDA Unclassified (pre-2012) initiated 12 Jun 2009

    There is a potential in the specified ESD (electrostatic discharge) protection circuitry in the keypad of Alaris PC units manufactured or serviced between April 2008 through January 2009. In these units there is a potential for the keypad not being responsive, key entries without key presses, or key entries that register incorrectly which may result in an over-infusion or under-infusion. An over

    • Terminated Z-1790-2009 FDA Unclassified (pre-2012) initiated 12 Jun 2009

    There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, an

    • Terminated Z-1794-2009 FDA Unclassified (pre-2012) initiated 12 Jun 2009

    There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Alaris
Generic Name
Bedside infusion pump, single-channel
Model / Reference
8015
Primary DI / UDI-DI
10885403801518
510(k) Number
FDA Product Code
FRN
GMDN Term
Bedside infusion pump, single-channel
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No