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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88558

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

Open FDA event record

Event summary

Timeline bucket
September 09, 2021
Product types
Device
Classifications
Class I
Statuses
Completed
Recalling firm wording
Vero Biotech, LLC

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

GENOSYL DS (Delivery System) console, for use as a vasodilator.

Z-2587-2021
Recall number
Z-2587-2021
Initiated
September 09, 2021
Classification
Class I
Status
Completed
Recalling firm
Vero Biotech, LLC
Quantity
120 consoles (3 consoles affected)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).

Code information

Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065)

Distribution pattern

Distributed within US to Texas and Illinois.