CLASS I Device recall · Reported 3 Jul 2019 · FDA Enforcement Report

enFlow Disposable Cartridge with IV Extension Set, used recalled

Vyaire Medical is recalling enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy, distributed nationwide in the US. The recall was initiated on 13 Mar 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart Number: 980202EU. All units distributed through March 7, 2019.

Quantity recalled5,782,820 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1386-2019
FDA event ID: 82393
Recalling firm: Vyaire Medical, Mettawa, IL
Classification: Class I
Status: Terminated
Recall initiated: 13 Mar 2019
FDA classified: 26 Jun 2019
Reported: 3 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Mar 2019	Recall initiated by company
26 Jun 2019	Classified by FDA	+105 days
3 Jul 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Part Number: 980202EU. All units distributed through March 7, 2019.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82393

This product is part of a recall event; the main page for the event is enFlow Disposable Cartridge, used recalled by Vyaire Medical.

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019	CLASS I	enFlow Disposable Cartridge, used recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide

More recalls from Vyaire Medical

All 63

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled	Vyaire Medical	Mold	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide