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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Auto ID Module Model 8600

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  Class 1 Device Recall Alaris Auto ID Module Model 8600 see related information
Date Initiated by Firm June 30, 2020
Date Posted August 06, 2020
Recall Status1 Terminated 3 on April 22, 2024
Recall Number Z-2723-2020
Recall Event ID 85691
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Code Information During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.
Recalling Firm/
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer 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.
FDA Determined
Cause 2
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, GMB-AlarisMedSafetyProgram@bd.com
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.