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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66120

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

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Event summary

Timeline bucket
June 10, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp.

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

SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

Z-0197-2014
Recall number
Z-0197-2014
Initiated
June 10, 2013
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
273,835 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

Code information

Product Code: 35700BAX, 35700ABB Serial Numbers: All

Distribution pattern

Worldwide Distribution-USA including Puerto Rico and Canada.