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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73315

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

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Event summary

Timeline bucket
February 12, 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 PC Unit, Infusion Pump Model 8000, Part No. TC10005092

Z-1239-2016
Recall number
Z-1239-2016
Initiated
February 12, 2016
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
170 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

Code information

Serial No. 4044845 9950535 4064411 12475162 4045659 9899143 3606478 4021398 4093501 4043745 4063430 4094994 9907675 9945292 9922622 4043375 12409069 4020663 12498854 4044531 4058193 12351849 4064030 9925068 12426138 4063830 4063911 9945269

Distribution pattern

Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.