Exact FDA event identifier

Event 86779

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

Open FDA event record

Event summary

Timeline bucket: November 11, 2020
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

(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CXFX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CXFX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.

Z-0565-2021

Recall number: Z-0565-2021
Initiated: November 11, 2020
Classification: Class II
Status: Terminated
Recalling firm: Terumo Cardiovascular Systems Corporation
Quantity: 5,079 Total: 523 US and 4,556 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

Code information

(1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837

Distribution pattern

US Nationwide Foreign: Belgium, India