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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81070

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

Open FDA event record

Event summary

Timeline bucket
September 13, 2018
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

Z-0176-2019
Recall number
Z-0176-2019
Initiated
September 13, 2018
Classification
Class II
Status
Terminated
Quantity
152

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The service manual was not updated at the time of the release of software version 1.30.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The service manual was not updated at the time of the release of software version 1.30.

Code information

All systems. UDI 00886799000588

Distribution pattern

US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.