Class 2 Device Recall BD Alaris" System

• Date Initiated by Firm: August 04, 2020
• Create Date: September 03, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2935-2020
• Recall Event ID: 85997
• 510(K)Number: K133532
• Product Classification: Infusion safety management software - Product Code PHC
• Product: BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.
• Code Information: Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Infusion pump component defect may result in interruption of patient monitoring
• FDA Determined Cause: Vendor change control
• Action: On 8/4/2020,the firm sent an "Urgent Medical Device Recall" letter to customers with FedEX tracking. A customer response form is included with the letter that the customer is instructed to email or fax back to the firm. Returned response forms will be reconciled with the customer list. A response card will be included with the customer letter that is to be mailed, emailed or faxed back to the firm and will be reconciled with the customer list. Customers that do not respond to the initial mailing will be contacted up to a total of 3 times. The firm's Customer Response Form provided E-mail address as : BDRC21@bd.com and fax no.: 1-312-949-0437. The firm instructed their customers to contact the recall support center at 1-888-562-6018 to schedule remediation of recalled modules at no charge. The firm provided an additional phone numbers and E-mail addresses as: (i) 888-812-3266 and Email: customerfeedback@bd.com for Product Complaints; (ii) 888-562-6018, SupportCenter@bd.com for Recall Related Questions and (iii) 888-812-3229, E-mail: DL-US-INF-TechSupport@bd.com Additionally, any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDAs MedWatch Program by: " Web: MedWatch website at www.fda.gov/medwatch " Phone: 1-800-FDA-1088 " Fax: 1-800-FDA-0178, or by " Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Quantity in Commerce: 680 units
• Distribution: U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None
• 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 = PHC