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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93648

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

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Event summary

Timeline bucket
March 28, 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

Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

Z-0693-2024
Recall number
Z-0693-2024
Initiated
March 28, 2023
Classification
Class I
Status
Ongoing
Quantity
195

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

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

Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

Code information

UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.

Distribution pattern

US: RI, CA, TX