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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93476

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

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Event summary

Timeline bucket
December 12, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Percussionaire Corporation

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

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Z-0637-2024
Recall number
Z-0637-2024
Initiated
December 12, 2023
Classification
Class I
Status
Ongoing
Quantity
2145 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly error

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

Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user

Code information

UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028

Distribution pattern

US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None

Field note

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