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Class 1 Device Recall enFlow Disposable Cartridge with IV Extension Set |
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Date Initiated by Firm |
March 13, 2019 |
Date Posted |
June 26, 2019 |
Recall Status1 |
Terminated 3 on September 22, 2020 |
Recall Number |
Z-1386-2019 |
Recall Event ID |
82393 |
510(K)Number |
K060537 K130867
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Product Classification |
Warmer, thermal, infusion fluid - Product Code LGZ
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Product |
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. |
Code Information |
Part Number: 980202EU. All units distributed through March 7, 2019. |
Recalling Firm/ Manufacturer |
Vyaire Medical 26125 N Riverwoods Blvd Mettawa IL 60045-3420
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Manufacturer Reason for Recall |
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
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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
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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.
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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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