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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89776

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

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Event summary

Timeline bucket
March 21, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Breas Medical, Inc.

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.

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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

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Z-0943-2022
Recall number
Z-0943-2022
Initiated
March 21, 2022
Classification
Class II
Status
Terminated
Recalling firm
Breas Medical, Inc.
Quantity
707 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Reason for recall

Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

Code information

Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849

Distribution pattern

US Nationwide