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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82393

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 13, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Vyaire Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1385-2019
Recall number
Z-1385-2019
Initiated
March 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
5,782,820 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: 980200EU. All units distributed through March 7, 2019.

Distribution pattern

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.

device · product 2 of 2

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

Z-1386-2019
Recall number
Z-1386-2019
Initiated
March 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
5,782,820 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.