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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Infusion Pump System

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  Class 1 Device Recall Alaris Infusion Pump System see related information
Date Initiated by Firm August 04, 2020
Create Date September 04, 2020
Recall Status1 Open3, Classified
Recall Number Z-2882-2020
Recall Event ID 86005
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product BD Alaris System; Alaris PCA Model 8120; P/N P0000031; Rx Only. Infusion pump for Patient Controlled Analgesia.
Code Information 8120 - PCA Module; 8110 - Syringe Module. See the uploaded consignee list for US product serial numbers.
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact Ms. Gail Griffiths
410-316-4054
Manufacturer Reason
for Recall
The Alaris PC unit to display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or over-infusion.
FDA Determined
Cause 2
Component design/selection
Action The recall letter was sent via FedEx, 2nd day air, on August 4, 2020. Following questions are provided to assist in describing the recall strategy in detail as follows: Action for Clinical Users: Ensure that the displayed syringe manufacturer and syringe size correctly identify the installed syringe. If the PC unit displays an incorrect syringe type and/or size, remove the device from service and send to Biomedical Engineering for repair. The biomedical engineer should: - Conduct a barrel clamp accuracy test as outlined in the "Preventive Maintenance" section of the BD Alaris" System Maintenance - Software User Manual and replace syringe barrel clamp mechanism if required. - Contact BD at 1-800-482-4822 to order a Syringe/PCA Sizer Sensor Replacement Kit at no charge, or - Contact the BD Recall Support Center at 888-562-6018 to send the module to the BD Service Depot for repair at no charge. Actions by BD: BD is redesigning the syringe barrel clamp mechanism as a quality improvement.
Quantity in Commerce 174,655 units
Distribution US - AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY OUS - AE, AU, BE, BH, CA, CH, CN, IN, KW, MX, MY, NL, NZ, PH, QA, SA, TW and ZA
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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