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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris EtCO2 Module

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  Class 2 Device Recall Alaris EtCO2 Module see related information
Date Initiated by Firm June 30, 2020
Date Posted August 19, 2020
Recall Status1 Open3, Classified
Recall Number Z-2825-2020
Recall Event ID 85919
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product Alaris EtCO2 Module Model 8300 - 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.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall		 LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
FDA Determined
Cause 2		 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 40671
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.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.
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