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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75353

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

Open FDA event record

Event summary

Timeline bucket
November 01, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CareFusion 303, 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

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

Z-1520-2017
Recall number
Z-1520-2017
Initiated
November 01, 2016
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
613,800 total units (575,221 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

Code information

all units

Distribution pattern

Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.