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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75466

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

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Event summary

Timeline bucket
December 02, 2016
Product types
Device
Classifications
Class I
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 Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

Z-0950-2017
Recall number
Z-0950-2017
Initiated
December 02, 2016
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
382,635 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.

Code information

All products manufactured or serviced in the time period October 2011 through June 2015.

Distribution pattern

Nationwide Distribution