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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82630

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 18, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems Corporation

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

1 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 1

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

Z-1337-2019
Recall number
Z-1337-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
1258

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.

Code information

All

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.