Z-2723-2020Class I

Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system

Name: Z-2723-2020 Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Creator: CareFusion 303, Inc.
Published: 2020-06-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-06-30 / Terminated / root cause: design

FDA source

CareFusion 303, Inc. began a recall of Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system on 2020-06-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2723-2020
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-08-06
Terminated: 2024-04-22
Recalling firm: CareFusion 303, Inc
Product: Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On 06/30/2020, Urgent Medical Device Recall Notifications were mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical Users: 1.Inspect the IUI connectors on each PC unit and module prior to each use. DO NOT use a device with any damage, cracks, or surface contaminants (e.g., blue or green deposits, corrosion, cleaning residue deposition) on the IUI connectors, or with broken IUI connector pins. If damage, deposits, residue, or corrosion is noticed, take the device out of service and send the unit to Biomedical Engineering for repair. 2.Ensure back-up devices are readily available when infusing critical medications where interruptions could cause serious injury or death. Please also ensure that you have back-up monitoring devices (e.g., EtCO2, SpO2) that are critically important to the patient's care. 3.If the issue occurs, expedite a replacement PC unit and modules to restart the infusions and monitoring. 4. Complete and return the Customer Response Card. Actions for Device Cleaning Personnel: Firm will provide existing customers a System Cleaning Kit (including IUI connector covers and cleaning brushes), Service Bulletin 630, Best Practices for Cleaning, and an updated System User Manual Addendum in August 2020. Actions for Biomedical Engineering: Expedite inspection of the IUI connectors on each PC unit and module at your facility. In addition, develop a system to check the IUI connectors prior to returning a unit to use from storage or repair. Replace any IUI connector with damage, cracks, surface contaminants or contact or pin damage on the IUI connectors. System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources and customer support: www.bd.com/alaris-system-hardware-recall Additional questions contact Recall Support Center: 858-617-1316, [email protected]
Quantity in commerce: 17767
Distribution: Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH
Product codes and lots: During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2723-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2716-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2717-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2718-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2719-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2720-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2721-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2722-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2723-2020	Class I	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-06

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)