Z-2822-2020Class II

Alaris Pump Module Model 8100 -

Name: Z-2822-2020 Alaris Pump Module Model 8100 -
Creator: CareFusion 303, Inc.
Published: 2020-06-30
License: https://open.fda.gov/license/

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

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters... on 2020-06-30. FDA classified it as Class II and gives the reason as "LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2822-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-30
Posted: 2020-08-19
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Product code: FRN Pump, Infusion
Reason for recall: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Root cause tag: design
FDA root cause: Device Design
Action: On 06/30/2020, Urgent Medical Device Recall Notifications will be mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical User: 1. If the end user observes a dim segment on the module, replace the module when feasible. There is no impact to the infusion. 2. Complete and return the Customer Response Card. Actions by Biomedical Engineering: If the module has a dim segment, please contactrecalling firm at 1-800-482-4822 to order a replacement display board (P/N TC10012952 for LVP Display Board, P/N TC10003525 for Syringe/PCA Display Board, P/N TC10008126 for EtCO2 Display Board, P/N TC10005026 for SpO2 Display Board) at no charge or send the module to the firm's Service Depot for repair. Actions by Recalling Firm: If the module has a dim segment as described in this notification, a replacement part will be provided at no charge. On 12/16/22, Medical Device Notifications were sent to customers informing them that they may have received impacted parts for repair purposes or (b) received product with impacted parts. Customers were provided with links to the original recall notices and asked to review the information and complete the customer response form.
Quantity in commerce: 1442097
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI and the 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, BH.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2822-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2822-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-19
Z-2823-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-19
Z-2824-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-19
Z-2825-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-19
Z-2826-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-19

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)