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Alaris™ Syringe Module, Model 8110 8100

by CareFusion 303, INC GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 19 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885403423208 UDI-DIDate19 Dec 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

35 recalls · 19 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-0186-2024 FDA Class I initiated 15 Sep 2023
    • Ongoing Z-0185-2024 FDA Class I initiated 15 Sep 2023
    • Ongoing Z-0184-2024 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.

  • 5 recalls, same reason

    • Ongoing Z-1544-2021 FDA Class I initiated 26 Mar 2021
    • Terminated Z-1543-2021 FDA Class I initiated 26 Feb 2021
    • Terminated Z-1332-2021 FDA Class I initiated 25 Feb 2021
    • Terminated Z-2204-2021 FDA Class I initiated 25 Feb 2021
    • Terminated Z-1331-2021 FDA Class I initiated 25 Feb 2021

    Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

    • Ongoing Z-1651-2021 FDA Class I initiated 25 Mar 2021

    Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

    • Ongoing Z-1375-2021 FDA Class I initiated 24 Mar 2021

    Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

    • Ongoing Z-1309-2021 FDA Class I initiated 3 Mar 2021

    Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay

  • 2 recalls, same reason

    • Ongoing Z-2910-2020 FDA Class I initiated 4 Aug 2020
    • Ongoing Z-2909-2020 FDA Class I initiated 4 Aug 2020

    The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

    • Ongoing Z-2935-2020 FDA Class II initiated 4 Aug 2020 via K133532, on the same 510(k)

    Infusion pump component defect may result in interruption of patient monitoring

    • Ongoing Z-2939-2020 FDA Class I initiated 4 Aug 2020

    Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

    • Ongoing Z-2882-2020 FDA Class I initiated 4 Aug 2020

    The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

  • 5 recalls, same reason

    • Ongoing Z-2822-2020 FDA Class II initiated 30 Jun 2020
    • Ongoing Z-2826-2020 FDA Class II initiated 30 Jun 2020
    • Ongoing Z-2825-2020 FDA Class II initiated 30 Jun 2020
    • Ongoing Z-2823-2020 FDA Class II initiated 30 Jun 2020
    • Ongoing Z-2824-2020 FDA Class II initiated 30 Jun 2020

    LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

    • Ongoing Z-1359-2020 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

  • 2 recalls, same reason

    • Terminated Z-2741-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2740-2020 FDA Class I initiated 30 Jun 2020

    If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.

  • 8 recalls, same reason

    • Terminated Z-2721-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2719-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2723-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2720-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2718-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2717-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2722-2020 FDA Class I initiated 30 Jun 2020
    • Terminated Z-2716-2020 FDA Class I initiated 30 Jun 2020

    Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

    • Terminated Z-2736-2020 FDA Class I initiated 30 Jun 2020

    Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

    • Terminated Z-1768-2019 FDA Class I initiated 13 Apr 2018

    The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Alaris™ Syringe Module, Model 8110
Generic Name
Bedside infusion pump, single-channel
Model / Ref / Catalog
8100, 8110SIXEN856
Primary DI / UDI-DI
10885403423208
510(k) Number
FDA Product Code
FRN
GMDN Term
Bedside infusion pump, single-channel
Device Class
Class II
Regulation Number
880.5725
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K133532)

Other devices from CareFusion 303, INC

See all devices from CareFusion 303, INC →

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