Class 1 Device Recall enFlow IV Fluid Warmer

• Date Initiated by Firm: March 13, 2019
• Date Posted: June 26, 2019
• Recall Status: Terminated on September 22, 2020
• Recall Number: Z-1385-2019
• Recall Event ID: 82393
• 510(K)Number: K060537 K130867
• Product Classification: Warmer, thermal, infusion fluid - Product Code LGZ
• Product: enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
• Code Information: Part Number: 980200EU. All units distributed through March 7, 2019.
• Recalling Firm/ Manufacturer: Vyaire Medical; 26125 N Riverwoods Blvd; Mettawa IL 60045-3420
• Manufacturer Reason for Recall: Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
• FDA Determined Cause: Device Design
• Action: Vyaire Medical notified consignees on about 03/13/2019 via URGENT NOTIFICATION OF RECALL letter. Consignees were instructed to conduct a 100% physical inventory to identify any affected product on hand, destroy all affected product in-stock in accordance with each facility's destruction protocol and if a facility is unable to destroy the product on site, or requires assistance, they were instructed to contact VyaireSupport@stericycle.com or call for assistance. Customers were also instructed to complete and return the Customer Response Form to VyaireSupport@stericycle.com, report any adverse reactions or quality problems to Vyaire's Technical Support Department by e-mail GMB-RS-DISP-Complaint-Intake@carefusion.com or telephone at 1-800-231-2466 prompt #1. If customers further distributed the product, they were instructed to forward a copy of the URGENT NOTIFICATION OF RECALL letter and Response Form to all customers and include the contact information to Vyaire for tracking purposes.
• Quantity in Commerce: 5,782,820 units total
• Distribution: Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, United Republic of Tanzania, South Africa, Panama, and Viet Nam.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LGZ; 510(K)s with Product Code = LGZ