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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82090

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

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Event summary

Timeline bucket
January 24, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Cardiovascular, 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

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

Z-0983-2019
Recall number
Z-0983-2019
Initiated
January 24, 2019
Classification
Class II
Status
Terminated
Quantity
7,880 each (1,576 packs of 5)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

Code information

Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745

Distribution pattern

Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.