Alaris™ Syringe Module, Model 8110
Alaris™ Syringe Module, Model 8110 v8.5.6 R
5manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | CareFusion 303, Inc, United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K133532 |
| Record published | 2025-12-19 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 5 to 90 % RH; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 50 to 101 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243855 | 2025-04-25 |
| K211218 | 2023-07-21 |
| K133532 | 2014-08-21 |
| K110535 | 2012-03-26 |
Recalls Naming This Product
34 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| CareFusion 303, Inc | 510(k) number | 2026-02-11 | Class II | Under Investigation by firm | 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 | 1,025,567 | |
| CareFusion 303, Inc | 510(k) number | 2023-09-15 | Class I | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. | 867,362 units | |
| CareFusion 303, Inc | 510(k) number | 2023-09-15 | Class I | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. | 133,727 units | |
| CareFusion 303, Inc | 510(k) number | 2023-09-15 | Class I | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. | 86,393 units | |
| Infusion Pump Repair | 510(k) number | 2021-03-26 | Class I | Component design/selection | 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 r | 15 | |
| The Biomed Guys | 510(k) number | 2021-03-25 | Class I | Under Investigation by firm | 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 fl | 22 units | |
| Pacific Medical Group Inc. | 510(k) number | 2021-03-24 | Class I | Component design/selection | 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 beze | 2452 | |
| CareFusion 303, Inc | 510(k) number | 2021-03-03 | Class I | Process design | 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 | 160300 | |
| Step-HAR Medical LLC | 510(k) number | 2021-02-26 | Class I | Component design/selection | 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 r | 2 | 2024-08-15 |
| Tenacore LLC | 510(k) number | 2021-02-25 | Class I | Component design/selection | 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 r | 474 | 2024-08-05 |
| Tenacore LLC | 510(k) number | 2021-02-25 | Class I | Component design/selection | 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 r | 1494 | 2024-08-05 |
| BioMedical Equipment Service Co (Bmes) | 510(k) number | 2021-02-25 | Class I | Component design/selection | 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 r | 718 potentially affected pumps | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-08-04 | Class I | Component design/selection | 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. | 180,186 parts & devices | |
| CareFusion 303, Inc | 510(k) number | 2020-08-04 | Class I | Reprocessing Controls | 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 pati | 313740 | |
| CareFusion 303, Inc | 510(k) number | 2020-08-04 | Class I | Reprocessing Controls | 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 pati | 28346 | |
| CareFusion 303, Inc | 510(k) number | 2020-08-04 | Class I | Device Design | 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 i | 248,519 | |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 37141 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 824277 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 1332354 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 122423 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 83532 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 38982 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 7854 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 a | 17767 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Device Design | 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 | 1093588 | 2024-04-23 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Nonconforming Material/Component | 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 los | 37141 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class I | Nonconforming Material/Component | 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 los | 824277 | 2024-04-22 |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class II | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. | 1442097 | |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class II | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. | 130612 | |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class II | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. | 89497 | |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class II | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. | 40671 | |
| CareFusion 303, Inc | 510(k) number | 2020-06-30 | Class II | Device Design | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. | 8558 | |
| CareFusion 303, Inc | 510(k) number | 2020-02-04 | Class I | Device Design | 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 al | 870070 | |
| CareFusion 303, Inc | 510(k) number | 2018-04-13 | Class I | Component design/selection | 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. externa | 607618 | 2023-12-26 |
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-06 | Class II | Under Investigation by firm | Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices w | 189 devices |
| 2025-10-17 | Class I | Device Design | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed f | 2,574,396 |
| 2025-07-08 | Class I | Under Investigation by firm | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. | 33,162,680 units total |
| 2025-07-08 | Class I | Under Investigation by firm | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. | 33,162,680 units total |
| 2025-01-23 | Class II | Under Investigation by firm | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left | 242,098 systems |
| 2024-08-15 | Class II | Process control | 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. | 20145 |
| 2024-08-15 | Class II | Process control | 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. | 10460 |
| 2024-08-15 | Class II | Process control | 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. | 180 |
| 2024-08-15 | Class II | Process control | 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. | 192964 |
| 2024-08-15 | Class II | Process control | 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. | 125017 device (finished devices and kits) |
| 2024-05-21 | Class II | Under Investigation by firm | Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. | 168 software version |
| 2023-01-24 | Class II | Software Design Change | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Use | 83,185 |
| 2020-02-04 | Class I | Device Design | 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 al | 83015 |
| 2020-02-04 | Class I | Device Design | 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 al | 114835 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.