FDA Medical Device Recalls (openFDA)
Vyaire Medical: enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
- Recall number
- Z-1386-2019
- Recalling firm
- Vyaire Medical
- Product
- enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
- Status
- Terminated
- Initiated
- 2019-03-13
- Posted
- 2019-06-26
- Terminated
- 2020-09-22
- Reason
- Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
- Root 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
- 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.
- Lot, serial or model codes
- Part Number: 980202EU. All units distributed through March 7, 2019.
- 510(k) numbers
- ["K060537","K130867"]
- PMA numbers
- not on file
- Product code
- LGZ
- Firm FEI
- 2050001
- Firm city
- Mettawa
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28