Z-1386-2019Class I

enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood...

Name: Z-1386-2019 enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood...
Creator: Vyaire Medical
Published: 2019-03-13
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2019-03-13 / Terminated / root cause: design

FDA source

Vyaire Medical began a recall of enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions on 2019-03-13. FDA classified it as Class I and gives the reason as "Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1386-2019
Classification: Class I
Status: Terminated
Initiated: 2019-03-13
Posted: 2019-06-26
Terminated: 2020-09-22
Recalling firm: Jaeger Medical GmbH
Product: enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Root cause tag: design
FDA 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 [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.
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.
Product codes and lots: Part Number: 980202EU. All units distributed through March 7, 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1386-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1385-2019	Class I	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1386-2019	Class I	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26

Product code LGZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)