enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
FDA Recall Z-1385-2019 · Posted 2019-06-26
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Recalling FirmVyaire Medical
Recall StatusTerminated
Product CodeLGZ
Date Initiated2019-03-13
Date Terminated2020-09-22
Product Quantity5,782,820 units total
Reason for Recall
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Firm 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 [email protected] or call for assistance. Customers were also instructed to complete and return the Customer Response Form to [email protected], report any adverse reactions or quality problems to Vyaire's Technical Support Department by e-mail [email protected] 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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