Class 1 Device Recall Alaris System PC Unit Model 8015

• Date Initiated by Firm: August 04, 2020
• Date Posted: September 04, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2909-2020
• Recall Event ID: 85900
• 510(K)Number: K133532
• Product Classification: Pump, infusion - Product Code FRN
• Product: Alaris System PC Unit Model 8015
• Code Information: All serial numbers manufactured from April 07, 2017 to Present.
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
• FDA Determined Cause: Reprocessing Controls
• Action: On 08/04/20, Urgent Medical Device Recall notices were mailed to Clinical Users: If the PC unit keypad becomes unresponsive or a key gets stuck, clinicians should remove the device from service and send to Biomedical Engineering. If administering a critical medication, continue the infusion until it is safe to replace the PC unit. Cleaning personnel can minimize the potential for fluid ingress during cleaning by 1) not using a cloth that drips, 2) wringing out the cleaning cloth to squeeze out excess fluid, and 3) not spraying fluids directly onto the device. Biomedical Engineering: If an affected PC unit has an unresponsive keypad or stuck key, remove the unit from service and call the recalling firm for information replacement parts. Until 510(k) clearance, the affected PC unit keypad design will continue to be provided for replacement or repair. Inspect all PC unit keypads for bubbling, cracks, damage, layer separations, and holes. Replace the front case keypad if it fails inspection. Return the completed Customer Response Form. Provide a copy of this letter and enclosures to customers who are currently renting affected devices. Firm is currently working on a design change for the PC unit keypad and will notify customers when replacement keypads are available. Additional Information: Customer Advocacy, 888-812-3266, customerfeedback@bd.com; Training Resources www.bd.com/alaris-system-hardware-recall; Recall Support Center, 888-562-6018, SupportCenter@bd.com; Technical Support, 888-812-3229, DL-US-INF-TechSupport@bd.com; Customer Order Management, 1-800-482-4822, GMB-CTS-CustCareInfusion@bd.com On 12/16/22, Medical Device Notifications were sent to customers informing them that they may have received impacted parts for repair purposes or 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: 313740
• Distribution: U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, 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.