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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92834

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

Open FDA event record

Event summary

Timeline bucket
August 04, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U

Z-2514-2023
Recall number
Z-2514-2023
Initiated
August 04, 2023
Classification
Class I
Status
Ongoing
Quantity
18,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

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

Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

Code information

UDI/DI 140267047147818, Lot code 3B085

Distribution pattern

US Nationwide distribution.