enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.

FDA device recall Z-1385-2019 · posted 2019-06-26 · Terminated

Recall details

Recalling firm

Vyaire Medical

Reason for recall

Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LGZ

Quantity affected

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, N

Date initiated

2019-03-13

Date posted

2019-06-26

Date terminated

2020-09-22

Location

Mettawa, IL

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