BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Sy

FDA device recall Z-2882-2020 · posted 2020-09-04 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

Action taken

The recall letter was sent via FedEx, 2nd day air, on August 4, 2020. On December 16, 2022, CareFusion expanded the recall to include additional affected customers. The notification was mailed via FedEx, 2nd day Air. 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.

Root cause

Component design/selection

Status

Open, Classified

Product code

FRN

Quantity affected

180,186 parts & devices

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,

Date initiated

2020-08-04

Date posted

2020-09-04

Location

San Diego, CA

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