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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68244

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

Open FDA event record

Event summary

Timeline bucket
June 17, 2014
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

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

Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

Z-2018-2014
Recall number
Z-2018-2014
Initiated
June 17, 2014
Classification
Class II
Status
Terminated
Quantity
1713 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

Code information

Catalog Number 801763

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.

device · product 2 of 2

Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

Z-2019-2014
Recall number
Z-2019-2014
Initiated
June 17, 2014
Classification
Class II
Status
Terminated
Quantity
1713 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

Code information

Catalog Number 801764

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.