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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80027

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

Open FDA event record

Event summary

Timeline bucket
April 26, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Draeger 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.

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

Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

Z-1954-2018
Recall number
Z-1954-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
Draeger Medical, Inc.
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

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

The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

Code information

Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009

Distribution pattern

Distributed to the states of CT, IL, MN, NV, SD, and WA.