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U.S. Department of Health and Human Services

Class 1 Device Recall enFlow IV Fluid Warmer

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  Class 1 Device Recall enFlow IV Fluid Warmer see related information
Date Initiated by Firm March 13, 2019
Create Date June 26, 2019
Recall Status1 Open3, Classified
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 2
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 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 = LGZ and Original Applicant = ENGINIVITY LLC
510(K)s with Product Code = LGZ and Original Applicant = VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
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