enFlow Disposable Cartridge with IV Extension Set, used for… recallZ-1386-2019 · Vyaire Medical · initiated Mar 13, 2019
Class I Terminated All recalls posted in June 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vyaire Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1386-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Mar 13, 2019
- Posted by the FDA
- Jun 26, 2019
- Recalling firm
- Vyaire Medical
- Quantity
- 5,782,820 units total
- Product code
- LGZ
- FDA submissions
- K130867, K060537
- 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.
Product description
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Code information (models, lots, serial numbers)
Part Number: 980202EU. All units distributed through March 7, 2019.
Other devices under the same FDA submission
3 devices cleared under K130867, K060537 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- enFlow™ 980105VSAirlife · Warmer, thermal, infusion fluid2 reports
- enFlow™ 980121EUAirlife · Warmer, thermal, infusion fluid1 report
- enFlow™ 980202EUAirlife · Warmer, thermal, infusion fluid1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 82393).
- Z-1385-2019 · TerminatedenFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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