CareFusion 303, Inc.: Alaris PCA Module Model 8120 - 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.

Recall number

Z-2824-2020

Recalling firm

CareFusion 303, Inc.

Product

Alaris PCA Module Model 8120 - 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.

Status

Open, Classified

Initiated

2020-06-30

Posted

2020-08-19

Terminated

not on file

Reason

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

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

89497

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.

Lot, serial or model codes

All serial numbers

510(k) numbers

["K133532"]

PMA numbers

not on file

Product code

FRN

Firm FEI

2016493

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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