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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92629

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
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 Sub-Acute Care Ventilator

Z-2248-2023
Recall number
Z-2248-2023
Initiated
July 12, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Draeger Medical, Inc.
Quantity
11,621 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

Code information

Part No. 5704110; UDI-DI 04048675398516; All Serial No.

Distribution pattern

US Nationwide Distribution.